A gas-sterilizable syringe having an aperture covered with a gas-permeable barrier that allows the entry and exit of sterilization gases while preventing leakage of fluid materials.

Abstract

The gas sterilizable syringe (100) includes an enclosure having walls defining a fluid chamber (105). A flowable material is disposed within the fluid chamber of the enclosure. A plunger (104) is assembled with the enclosure and is movable toward a distal end of the enclosure to dispense the flowable material. One or more apertures (126) are formed in at least one of the walls of the enclosure. A gas permeable barrier (544) covers at least one of the apertures formed in at least one of the walls of the enclosure to allow sterilization gas to pass through the at least one aperture covered by the gas permeable barrier while preventing the flowable material from passing through the at least one of the apertures. The gas permeable barrier is permeable to the sterilization gas and impermeable to the flowable material disposed within the fluid chamber of the enclosure.

Description

Technical Field

[0001] (Cross - reference to related applications) This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 209,434, filed on June 11, 2021 (Attorney Docket No. ETH6121USPSP1), U.S. Provisional Patent Application No. 63 / 231,494, filed on August 10, 2021 (Attorney Docket No. ETH6132USPSP1), and U.S. Provisional Patent Application No. 63 / 233,910, filed on August 17, 2021 (Attorney Docket No. ETH6120USPSP1), the disclosures of which are incorporated herein by reference. This patent application is related to U.S. Patent Application Publication No. 17 / 667,969 (Attorney Docket No. ETH6141USNP1) by the same applicant, filed simultaneously with this patent application, the disclosure of which is incorporated herein by reference.

[0002] (Field of the Invention) This patent application generally relates to medical devices, and more specifically to syringes used to eject a flowable material.

Background Art

[0003] (Description of related art) It is important to maintain a sterile state during surgical procedures to protect patients and promote healing and recovery after treatment. It is also necessary to sterilize medical devices, instruments, and components used during surgical procedures.

[0004] Therefore, many efforts have been made to provide sterile medical devices and surgical instruments. In some examples, medical devices and surgical instruments are placed inside packages and containers for sterilization. For example, U.S. Patent No. 7,909,249 to Bagozzi et al. discloses a steam-sterilizable apparatus designed to hold a medical device. The apparatus includes a capsule having a shape that conforms to the shape of the medical device to be placed inside the capsule. The apparatus includes an enclosure configured to house the medical device in cooperation with the capsule. The capsule and / or enclosure may include openings that allow steam to enter and exit the apparatus for sterilizing the medical device (e.g., an implant).

[0005] U.S. Patent No. 8,276,348 to Mermet et al. discloses a container designed to hold one or more objects for sterilization. The container has an inlet opening and an outlet opening through which one or more objects can enter and exit the container. The container includes a rigid portion having a perforated perimeter and a non-rigid portion that is porous to sterilization fluid and non-porous to microbial contamination. The porosity of the openings in the rigid portion and the non-rigid portion of the container allows for sufficient diffusion of the sterilization fluid inside the rigid and non-rigid portions, and around the one or more objects contained within the rigid portion.

[0006] U.S. Patent No. 4,154,342 to Wallace discloses a sterilizable package for medical or surgical instruments. The package comprises a rigid or semi-rigid container containing a filter element made of porous plastic, which is adapted to allow the passage of sterile gases while preventing bacteria from entering the package.

[0007] International Publication No. 2014 / 187779 discloses a method for sterilizing the surface of a pre-filled syringe. The syringe is placed inside a package consisting of one or more gas-permeable materials. The sterilization method is carried out at a low temperature of 15 to 50 degrees Celsius.

[0008] U.S. Patent No. 10,710,759 to Lu et al. discloses a method for packaging pre-filled medical devices. The method involves manufacturing a package having a front panel and a back panel defining compartments capable of holding one or more medical devices. At least one of the front panel or top panel has a portion containing a gas-permeable material, and the rest of the pouch is gas-impermeable. The gas-permeable material allows sterilization gas to pass through the material and come into contact with one or more articles contained within the compartments. Once sterilization is complete, the pouch is sealed, and the gas-permeable portion is cut off, leaving the sterilized medical devices sealed in a completely gas-impermeable pouch.

[0009] Furthermore, efforts have been made to sterilize medical devices without placing them inside a container for sterilization. For example, U.S. Patent No. 8,617,483 to Fischer et al. discloses a system for sterilizing fluid implant material after it has been packaged inside a sealed syringe. The system includes a porous sleeve that fits inside the syringe and is in fluid communication with the atmosphere outside the syringe. By positioning the porous sleeve adjacent to the fluid implant material, a path with the lowest resistance to gas permeability is created at the open end of the container, effectively reducing the maximum gas permeability length through the fluid implant material packaged inside the sealed syringe, thereby enabling sterilization of the fluid implant material with a gaseous agent while it is inside the syringe.

[0010] U.S. Patent No. 10,064,990 to Sodhi discloses a syringe assembly having a fluid path that can be sterilized by gas or radiation. The syringe assembly includes a plunger rod, a syringe barrel, and a first cap and a second cap that allow sterilization of a portion of the fluid path by radiation or gas. The structural features that provide sterilization of the fluid path make it possible to keep the fluid path sterile without requiring external packaging material surrounding the syringe assembly.

[0011] U.S. Patent No. 8,435,217 to Winn discloses a gas-sterilizable delivery system for two-component polymers. The delivery system comprises at least two syringe barrels, each sealed with a gas-permeable plunger seal that allows a sterilizing gas to permeate through the plunger seal for gas-sterilizing the assembly. [Overview of the Initiative] [Problems that the invention aims to solve]

[0012] Despite the advancements described above, there is still a need for systems, devices, and methods for easily and effectively sterilizing syringes and the materials loaded into them, and for maintaining syringes and pre-loaded materials in a sterile state before and during medical procedures.

[0013] Furthermore, there is a need for low-cost, readily available, and sterilizable syringes that can be used to dispense precursors (e.g., silicone-based polymers) having relatively high viscosity (e.g., up to 1,000,000 centipoise), thereby enabling the bonding (e.g., mixing) of precursors to form a tissue adhesive. [Means for solving the problem]

[0014] In one embodiment, a gas-sterilizable syringe preferably comprises an enclosure having one or more walls defining a fluid chamber, and a viscous fluid material (e.g., a silicone polymer, a precursor used to form a tissue adhesive) disposed within the fluid chamber.

[0015] In one embodiment, the enclosure preferably includes a movable plunger (e.g., a syringe plunger with a piston) for dispensing a viscous, fluid material.

[0016] In one embodiment, the enclosure preferably includes a plurality of micro-apertures formed in at least one of the enclosure walls that are in fluid communication with the fluid chamber. The micro-apertures preferably have a geometric shape and / or size (e.g., cross-sectional diameter) that allows a sterilization gas (e.g., ethylene oxide) to pass through the micro-aperture while preventing a viscous fluid material from passing through. Thus, the micro-apertures are preferably large enough to allow the sterilization gas to pass through, but small enough to prevent the viscous fluid material from leaking out of the micro-aperture when positive pressure is applied to dispense the viscous fluid material.

[0017] In one embodiment, the enclosure may include a syringe barrel having a distal end wall, a dispensing tip protruding from the distal end wall of the syringe barrel, an end cap fixed to the distal end of the dispensing tip, and a piston fixed to the distal end of the plunger.

[0018] In one embodiment, the microaperture preferably has an inner diameter ID1 of about 0.1 microns to about 25 microns, more preferably about 1 micron.

[0019] In one embodiment, the viscous fluid material preferably has a viscosity of about 1,000 to 100,000 centipoise, more preferably about 2,000 to 75,000 centipoise, and even more preferably about 30,000 to 60,000 centipoise.

[0020] In one embodiment, a sterilizing gas (e.g., ethylene oxide) can pass through micro-apertures formed in one or more walls of an enclosure to sterilize a viscous flowable material disposed within a fluid chamber. However, during the dispensing operation, when the viscous flowable material is being dispensed under positive pressure, the viscosity of the flowable material is relatively high, preventing the flowable material from passing through the micro-apertures and / or leaking from the micro-apertures.

[0021] In one embodiment, a sterilizable syringe can include micro-apertures or micro-holes formed in one or more walls of a syringe barrel, a syringe plunger, a piston, a dispensing tip, and / or an end cap that preferably covers a dispensing opening at a distal end of the dispensing tip.

[0022] In one embodiment, micro-apertures can be formed within one or more components of a syringe using various systems, devices, and methods. For example, in one embodiment, a laser device can be used to laser drill micro-apertures in one or more components of a syringe.

[0023] In one embodiment, laser drilling of polymeric materials or glass, in particular, is very fast and cost-effective, and many micro-apertures can be drilled or formed in a syringe within a short time (e.g., a few seconds) using a laser drill.

[0024] In one embodiment, a mechanical component such as a micro-drill can be used to form micro-apertures in one or more components of a syringe.

[0025] In one embodiment, a heated probe can be used to form micro-apertures in a syringe, thereby melting a material (e.g., a polymeric material) using the heated probe to form the micro-apertures.

[0026] In one embodiment, a water jet can be used to form micro apertures in one or more components of a syringe.

[0027] In one embodiment, the viscous fluidic material is preferably a high-viscosity precursor used to make a tissue adhesive. A viscous precursor (e.g., a silicone polymer) used to make a tissue adhesive does not leak through very narrow micro apertures having a diameter of about 0.1 micron to about 25 microns, more preferably about 1 micron. The diameter of each micro aperture is such that at the vacuum and pressure used, a viscous fluidic material (e.g., a silicone fluid) can leak through the micro aperture, but the quantity / area density of the micro apertures is selected to be sufficient to allow a sterilizing gas (e.g., ethylene oxide gas) to penetrate into the syringe and sterilize the syringe and the enclosed viscous fluidic material.

[0028] In one embodiment, the syringe barrel preferably has a cylindrical wall extending from the proximal end to the distal end of the syringe barrel.

[0029] In one embodiment, the syringe barrel can be made from a polymeric material or glass.

[0030] In one embodiment, at least some of the micro apertures of the enclosure are formed in the outer cylindrical wall of the syringe barrel.

[0031] In one embodiment, the syringe preferably includes a distal end wall that partially closes the distal end of the syringe barrel. In one embodiment, the distal end wall preferably has an opening for dispensing a viscous fluidic material loaded within the syringe barrel.

[0032] In one embodiment, at least some of the micro apertures are formed in the distal end wall of the syringe barrel.

[0033] In one embodiment, micro-apertures formed on the distal end wall are in fluid communication with the fluid chamber and have sizes that allow a sterilization gas (e.g., ethylene oxide) to pass through to sterilize viscous fluid materials, but prevent the passage of viscous fluid materials.

[0034] In one embodiment, the syringe includes a dispensing tip that protrudes from the distal end wall of the syringe barrel for dispensing a viscous, fluid material.

[0035] In one embodiment, the dispensing tip includes a tubular outer wall that defines a conduit communicating with the fluid chamber.

[0036] In one embodiment, at least some of the microapertures are formed on the tubular outer wall of the dispensing tip. The dispensing tip microapertures are preferably in fluid communication with the fluid chamber.

[0037] In one embodiment, micro-apertures formed on the tubular outer wall of the dispensing tip are in fluid communication with the fluid chamber and have sizes that allow a sterilization gas (e.g., ethylene oxide) to pass through the micro-aperture to sterilize viscous fluid materials, while preventing viscous fluid materials from passing through the micro-aperture.

[0038] In one embodiment, the syringe preferably includes an end cap fixed to the distal end of the outer wall of the dispensing tip.

[0039] In one embodiment, at least some of the microapertures are formed in the end cap.

[0040] In one embodiment, the micro-aperture formed in the end cap is in fluid communication with the fluid chamber and has a shape or size (e.g., cross-sectional diameter) that allows a sterilization gas (e.g., ethylene oxide) to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through.

[0041] In one embodiment, the syringe plunger has a distal end that includes a piston having an outer circumference that engages with the inner surface of the cylindrical wall of the syringe barrel defining the fluid chamber.

[0042] In one embodiment, at least some of the micro-apertures of the enclosure are formed on the piston.

[0043] In one embodiment, the micro-apertures formed on the piston are in fluid communication with the fluid chamber and have a geometric shape or size (e.g., cross-sectional diameter) that allows a sterilization gas (e.g., ethylene oxide) to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through.

[0044] In one embodiment, the enclosure for a gas-sterilizable syringe preferably has a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends of the enclosure.

[0045] In one embodiment, at least some of the microapertures formed in the enclosure preferably extend along their respective axes perpendicular to the longitudinal axis of the enclosure.

[0046] In one embodiment, at least some of the microapertures formed in the enclosure preferably extend along their respective axes, which are parallel to the longitudinal axis of the syringe barrel.

[0047] In one embodiment, at least some of the microapertures formed in the enclosure preferably extend along their respective axes, which are oblique to the longitudinal axis of the syringe barrel.

[0048] In one embodiment, the micro-aperture formed within the enclosure is located adjacent to the proximal end of the enclosure.

[0049] In one embodiment, a gas-sterilizable syringe may include a microporous layer, film, or sleeve (hereinafter referred to as the "microporous layer") covering at least some of the microapertures formed on the syringe. The microporous layer (e.g., made from TYVEK® or a TYVEK-like material) allows the sterilization gas to pass through while preventing the passage of viscous, fluid material placed in the fluid chamber of the enclosure. The microporous layer may be made of a synthetic material, such as a synthetic material made from flash-spun high-density polyethylene fibers.

[0050] In one embodiment, the microporous layer covers at least one outer surface of the enclosure wall (for example, the outer surface of the cylindrical wall of a syringe barrel).

[0051] In one embodiment, the microporous layer covers at least one inner surface of the enclosure wall (for example, the inner surface of the cylindrical wall of a syringe barrel).

[0052] In one embodiment, the microporous layer preferably covers one or more microapertures formed on the components of the sterilizable syringe to allow a sterilizing gas to pass through the microporous layer and one or more microapertures covered by the microporous layer.

[0053] In one embodiment, a gas-sterilizable syringe may include a protective sleeve (e.g., a non-porous sleeve) that covers the outer surface of the outer wall of the enclosure (e.g., the syringe barrel).

[0054] In one embodiment, the syringe barrel has a cylindrical outer wall, and the protective sleeve has a cylindrical shape that fits the cylindrical outer wall of the syringe barrel.

[0055] In one embodiment, the protective sleeve is movable between an extended position to cover at least some of the micro-apertures and a retracted position to expose at least some of the micro-apertures without covering them. In one embodiment, a sterilizable syringe is sterilized with the protective sleeve in the retracted position so that sterilization gas can pass through the uncovered micro-apertures. After sterilization, the protective sleeve may be moved to the extended position to cover the micro-apertures while the syringe is packaged, shipped, stored, and / or used. In one embodiment, in the extended position, the protective sleeve may cover one or more of the micro-apertures to prevent viscous fluid material from leaking through the micro-apertures.

[0056] In one embodiment, the micro-aperture may extend entirely through at least one of the enclosure walls, from the outer surface to the inner surface of the wall.

[0057] In one embodiment, at least one of the walls of the enclosure preferably has an outer surface and an inner surface, and at least some of the micro-apertures may include a blind opening having an open outer end exposed on the outer surface of the wall and a closed inner end spaced apart from the inner surface of the wall.

[0058] In one embodiment, the enclosure wall preferably includes a membrane located between the closed inner end of the blind opening of the micro-aperture and the inner surface of the enclosure wall. The membrane is preferably thin enough to allow sterilization gas to pass through, but thick enough to prevent viscous, fluid material from passing through and / or leaking out of the micro-aperture.

[0059] In one embodiment, a gas-sterilizable syringe preferably includes a syringe barrel having an outer wall defining and / or surrounding a fluid chamber, a viscous fluid material disposed within the fluid chamber, and a syringe plunger assembled together with the syringe barrel.

[0060] In one embodiment, the gas-sterilizable syringe preferably includes a plurality of micro-apertures formed on the outer wall of the syringe barrel that are in fluid communication with the fluid chamber.

[0061] In one embodiment, the multiple micro-apertures have a shape and / or size (e.g., cross-sectional diameter) that allows a sterilizing gas to pass through the micro-apertures to sterilize the viscous fluid material, such as during a dispensing operation in which a plunger is used to generate positive pressure applied to the viscous fluid material, while preventing the viscous fluid material from passing through and / or leaking out of the micro-apertures.

[0062] In one embodiment, the micro-aperture has openings that extend from the outer surface to the inner surface of the outer wall of the syringe barrel.

[0063] In one embodiment, each opening of the microaperture has an inner diameter of 0.1 to 25 microns.

[0064] In one embodiment, each opening of the microaperture has an inner diameter of 1 micron.

[0065] In one embodiment, the gas-sterilizable syringe preferably includes a microporous layer that covers the surface of the outer wall of the syringe barrel and covers at least some of the microapertures.

[0066] In one embodiment, the microporous layer preferably allows sterilization gases to pass through while preventing viscous, fluid materials from passing through and / or leaking out.

[0067] In one embodiment, the microporous layer may be a material sold under the trademark TYVEK®, which is a brand of flash-spun high-density polyethylene fiber, or a synthetic material that is structurally and functionally similar to the TYVEK® brand.

[0068] In one embodiment, the gas-sterilizable syringe preferably includes a protective sleeve that covers the outer surface of the outer wall of the syringe barrel.

[0069] In one embodiment, the protective sleeve is movable between an extended position to cover at least some of the micro-apertures and a retracted position to expose at least some of the micro-apertures without covering them.

[0070] In one embodiment, the microaperture extends completely through the outer wall of the syringe barrel, from the outer surface of the outer wall of the syringe barrel to the inner surface of the outer wall of the syringe barrel.

[0071] In one embodiment, the micro-aperture includes a blind opening having an open outer end exposed to the outer surface of the outer wall of the syringe barrel and a closed inner end spaced apart from the inner surface of the outer wall of the syringe barrel that defines the fluid chamber.

[0072] In one embodiment, the outer wall of the syringe barrel preferably includes a membrane located between the closed inner end of the blind opening of the microaperture and the inner surface of the outer wall of the syringe barrel. Sterilization gases can diffuse through the membrane, but viscous fluid materials cannot pass through the membrane.

[0073] In one embodiment, the syringe plunger has a distal end including a piston, which is disposed within a fluid chamber and engages with a viscous fluid material.

[0074] In one embodiment, the outer wall of the syringe barrel includes a cylindrical wall containing some of the microapertures.

[0075] In one embodiment, the syringe barrel preferably includes a distal end wall in which a micro-aperture is formed that is in fluid communication with the fluid chamber.

[0076] In one embodiment, the microapertures formed on the distal end wall preferably have a geometric shape and / or size that allows a sterilizing gas to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through.

[0077] In one embodiment, the gas-sterilizable syringe preferably includes a dispensing tip that protrudes from the distal end wall of the syringe barrel and is in fluid communication with the fluid chamber of the syringe barrel.

[0078] In one embodiment, the dispensing tip preferably has an outer wall in which a micro-aperture is formed that is in fluid communication with the fluid chamber.

[0079] In one embodiment, the micro-aperture formed at the dispensing tip preferably has a geometric shape and / or size that allows a sterilization gas to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through.

[0080] In one embodiment, a gas-sterilizable syringe may include an end cap connected to the distal end of the dispensing tip. The end cap may be removed from the dispensing tip before dispensing a viscous, fluid material.

[0081] In one embodiment, the end cap may include an end cap micro-aperture formed internally and in fluid communication with the fluid chamber.

[0082] In one embodiment, the micro-apertures formed in the end cap preferably have geometric shapes and / or sizes that allow a sterilization gas to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through.

[0083] In one embodiment, the piston has an outer circumference that engages with the inner surface of the wall of the syringe barrel defining the fluid chamber.

[0084] In one embodiment, the piston preferably includes a piston microaperture formed internally and extending through the piston to communicate fluidly with a fluid chamber.

[0085] In one embodiment, the micro-apertures formed on the piston preferably have shapes and / or sizes that allow a sterilizing gas to pass through to sterilize the viscous fluid material, while preventing the viscous fluid material from passing through the piston.

[0086] In one embodiment, one or more micro-apertures may be perforated in the piston of the syringe plunger. In one embodiment, any fluid material escaping through the micro-apertures formed in the piston is preferably trapped within the posterior / proximal section of the syringe barrel so as not to come into contact with the user's hand.

[0087] In one embodiment, the gas-sterilizable syringe preferably includes a syringe barrel having a cylindrical outer wall and a distal end wall that closes the distal end of the cylindrical outer wall.

[0088] In one embodiment, the cylindrical outer wall and distal end wall define the fluid chamber of the syringe barrel.

[0089] In one embodiment, the gas-sterilizable syringe preferably includes a dispensing tip protruding from the distal end wall. The dispensing tip preferably has a conduit that communicates with a fluid chamber.

[0090] In one embodiment, the gas-sterilizable syringe preferably has an end cap that covers the distal end of the dispensing tip.

[0091] In one embodiment, a viscous fluid material is disposed within the fluid chamber of a syringe barrel, and a syringe plunger is assembled with the syringe barrel and is movable toward the distal end wall of the syringe barrel to dispense the viscous fluid material from the distal end of the dispensing tip.

[0092] In one embodiment, a plurality of micro-apertures may be formed on the cylindrical outer wall of a syringe barrel that is in fluid communication with a fluid chamber. In one embodiment, the micro-apertures have a geometric shape and / or size (e.g., cross-sectional diameter) that allows a sterilization gas (e.g., ethylene oxide) to pass through to sterilize viscous fluid materials, while preventing the passage of viscous fluid materials.

[0093] In one embodiment, a gas-sterilizable syringe preferably includes a microporous layer covering at least some of the microapertures, thereby preventing the passage of viscous fluid materials while allowing the sterilization gas to pass through.

[0094] In one embodiment, the microporous layer is in contact with the outer surface of the cylindrical wall of the syringe barrel.

[0095] In one embodiment, the microporous layer is in contact with the inner surface of the cylindrical wall of the syringe barrel.

[0096] In one embodiment, a gas-sterilizable syringe may include a distal end wall in which a distal end wall microaperture is formed, which is in fluid communication with the fluid chamber of the syringe barrel.

[0097] In one embodiment, the distal end wall microaperture has a cross-sectional diameter that allows a sterilization gas to pass through while preventing a viscous, fluid material from passing through.

[0098] In one embodiment, the microporous layer may cover at least some of the distal endwall microapertures.

[0099] In one embodiment, a gas-sterilizable syringe may include a dispensing tip with a dispensing tip micro-aperture formed on its outer wall, which communicates with the fluid chamber of the syringe barrel.

[0100] In one embodiment, the dispensing tip micro-aperture has a cross-sectional diameter that allows sterile gas to pass through while preventing viscous, fluid material from passing through.

[0101] In one embodiment, the microporous layer may cover at least some of the microapertures formed at the dispensing tip.

[0102] In one embodiment, the gas-sterilizable syringe preferably includes an end cap having an end cap micro-aperture that is in fluid communication with the fluid chamber of the syringe barrel.

[0103] In one embodiment, the micro-apertures formed in the end cap have respective geometric shapes and / or sizes (e.g., cross-sectional diameter) that allow sterilization gases to pass through while preventing viscous, fluid materials from passing through.

[0104] In one embodiment, the microporous layer preferably covers at least some of the microapertures formed on the end cap.

[0105] In one embodiment, a gas-sterilizable syringe may include a protective sleeve that covers the outer surface of the cylindrical outer wall of the syringe barrel.

[0106] In one embodiment, the protective sleeve is movable between an extended position to cover at least some of the micro-apertures and a retracted position to expose at least some of the micro-apertures without covering them.

[0107] In one embodiment, a sterilizable syringe may include various components such as an enclosure, including a syringe barrel having a distal end wall that partially closes the distal end of the enclosure; a syringe plunger having a piston that forms an internal seal of the enclosure; a dispensing tip; and an end cap configured to cover the distal end of the dispensing tip.

[0108] In one embodiment, the enclosure may be a syringe or vial made of polymer material and / or glass.

[0109] In one embodiment, the piston may be made from a polymer material and / or rubber.

[0110] In one embodiment, the syringe is preferably designed to dispense a viscous fluid material such as a precursor and / or component (e.g., a silicone polymer) that can be used to form a tissue adhesive, more preferably a high-viscosity fluid precursor (e.g., a silicone polymer) that can be used to prepare a tissue adhesive.

[0111] In one embodiment, a micro-aperture formed on the outer wall of the syringe barrel is preferably located near the piston's position at the proximal end of the syringe barrel at the start of the dispensing procedure, so that as the piston advances distally toward the distal end of the syringe barrel, the piston moves into an area of ​​the outer wall of the syringe barrel without a micro-aperture, preventing leakage of the fluid material (as the piston moves distally to the micro-aperture) and providing continuous dispensing of the fluid material.

[0112] In one embodiment, the micro-aperture formed on the syringe may be a blind micro-aperture, which does not completely penetrate through the wall defining the fluid chamber, thereby leaving a small portion of the wall intact as a very thin film that can be permeated by a sterilization gas (e.g., ethylene oxide gas) to sterilize the viscous fluid material loaded into the syringe barrel.

[0113] In one embodiment, a gas-sterilizable syringe includes an enclosure having walls defining a fluid chamber, a fluid material disposed within the fluid chamber of the enclosure, and a plunger assembled with the enclosure and movable toward the distal end of the enclosure for dispensing the fluid material from the enclosure.

[0114] In one embodiment, one or more apertures can be formed in at least one of the walls of the enclosure. In one embodiment, a gas permeable barrier covers at least one of the apertures formed in at least one of the walls of the enclosure to allow a sterilization gas to pass through at least one of the apertures covered by the gas permeable barrier, while preventing a fluid material from passing through at least one of the apertures covered by the gas permeable barrier.

[0115] In one embodiment, a gas-permeable barrier covering at least one of the apertures formed in at least one of the walls of the enclosure is permeable to sterilization gases and impermeable to fluid materials placed in the fluid chamber of the enclosure.

[0116] In one embodiment, the gas permeable barrier has a porosity that is high enough to allow the entry and exit of sterilization gases during the sterilization procedure, but low enough to prevent the flowable material from passing through the gas permeable barrier.

[0117] In one embodiment, one or more apertures formed in at least one of the walls of the enclosure include a plurality of apertures formed in at least one of the walls of the enclosure.

[0118] In one embodiment, the gas permeable barrier comprises a plurality of gas permeable bodies that fill each of a plurality of apertures formed in at least one of the walls of the enclosure.

[0119] In one embodiment, each of the multiple gas-permeable bodies filling each of the multiple apertures is coupled to at least one of the walls of the enclosure.

[0120] In one embodiment, the gas permeable barrier may be made from silicone, room temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), high consistency rubber (HCR), and synthetic flash-spun high-density polyethylene fibers (e.g., a TYVEK® layer).

[0121] In one embodiment, the sterilization gas may include ethylene oxide, and the fluid material may include a liquid, a topical skin adhesive, and / or a silicone-based topical skin adhesive.

[0122] In one embodiment, the enclosure may include a syringe barrel surrounding a fluid chamber, a dispensing opening located at the distal end of the syringe barrel, and a plunger movable toward the distal end of the syringe barrel for dispensing a fluid material through the dispensing opening located at the distal end of the syringe barrel.

[0123] In one embodiment, a gas permeable barrier covers the dispensing opening to allow sterile gas to pass through, while preventing fluid material from passing through.

[0124] In one embodiment, a gas-sterilizable syringe may include an end cap fixed to the distal end of the syringe barrel and covering the dispensing opening. In one embodiment, one or more end cap openings may be formed in the end cap to allow sterilization gas to pass through the end cap.

[0125] In one embodiment, the gas permeable barrier is disposed inside the end cap and is located between one or more end cap openings and the dispensing opening at the distal end of the syringe barrel.

[0126] In one embodiment, the end cap has a central hub that engages with the distal end wall of the syringe barrel to form an airtight seal between the central hub of the end cap and the distal end wall of the syringe barrel.

[0127] In one embodiment, the gas-sterilizable syringe preferably includes a dual-barrel syringe comprising a first syringe barrel having a first fluid chamber and a first fluid dispensing opening, and a second syringe barrel having a second fluid chamber and a second fluid dispensing opening.

[0128] In one embodiment, a gas-sterilizable syringe may include a dual-barrel plunger comprising a first plunger disposed in a first fluid chamber of a first syringe barrel and a second plunger disposed in a second fluid chamber of a second syringe barrel.

[0129] In one embodiment, the end cap is removably fixed to the distal end of the dual-barrel syringe to cover the first and second fluid dispensing openings.

[0130] In one embodiment, the end cap has at least one end cap opening formed inside.

[0131] In one embodiment, a gas permeable barrier is disposed within the end cap and is located between at least one end cap opening and the first and second fluid dispensing openings of the first and second syringe barrels, respectively.

[0132] In one embodiment, the fluid material includes a first portion and a second portion configured to be mixed with each other. In one embodiment, the first portion of the fluid material is disposed in a first fluid chamber of a first syringe barrel, and the second portion of the fluid material is disposed in a second fluid chamber of a second syringe barrel.

[0133] In one embodiment, the gas permeable barrier preferably covers the first and second fluid dispensing openings of the first and second syringe barrels. The gas permeable barrier allows sterile gas to pass through the first and second fluid dispensing openings, while preventing the first and second portions of the fluid material from passing through the first and second fluid dispensing openings.

[0134] In one embodiment, the end cap includes a hub that engages with the distal end wall of the dual-barrel syringe to form an airtight seal between the end cap hub and the distal end wall of the dual-barrel syringe.

[0135] In one embodiment, the end cap hub has a proximal end that is open to receive a first fluid dispensing opening and a second fluid dispensing opening, and a distal end that is closed by a distal end wall containing at least one end cap opening.

[0136] In one embodiment, the end cap preferably includes at least one radially extending projection that extends outward from the outer surface of the end cap hub.

[0137] In one embodiment, the dual-barrel syringe preferably includes at least one retaining flange protruding from the distal end wall of the dual-barrel syringe. The at least one retaining flange is configured to engage with at least one radially extending projection of the end cap hub to releasably secure the end cap to the distal end wall of the dual-barrel syringe.

[0138] In one embodiment, a gas-sterilizable syringe preferably includes an applicator tip configured to extrude a fluid material from the distal end of a dual-barrel syringe. The applicator tip preferably includes a dispensing tube having a proximal and distal end, an applicator tip connector fixed to the proximal end of the dispensing tube, and a static mixer disposed within the dispensing tube.

[0139] In one embodiment, the applicator tip connector preferably has at least one radially extending projection, the at least one radially extending projection configured to engage with at least one fixed flange protruding from the distal end wall of the dual-barrel syringe in order to releasably secure the applicator tip to the distal end wall of the dual-barrel syringe.

[0140] In one embodiment, the gas-permeable barrier is permeable to sterilization gas but impermeable to the first and second portions of the fluid material. Therefore, sterilization gas can flow through the gas-permeable barrier, but the first and second portions of the fluid material cannot.

[0141] In one embodiment, the gas permeable barrier has a porosity high enough to allow the entry and exit of sterilization gases during the sterilization procedure, but low enough to prevent the first and second portions of the fluid material from passing through the gas permeable barrier.

[0142] In one embodiment, the gas-sterilizable syringe preferably includes a dual-barrel syringe comprising a first syringe barrel and a second syringe barrel. The first syringe barrel preferably includes a first fluid chamber and a first fluid dispensing opening located at the distal end of the first syringe barrel, and the second syringe barrel preferably includes a second fluid chamber and a second fluid dispensing opening located at the distal end of the second syringe barrel.

[0143] In one embodiment, a first portion of the fluid material is disposed in a first fluid chamber of a first syringe barrel, and a second portion of the fluid material is disposed in a second fluid chamber of a second syringe barrel.

[0144] In one embodiment, a dual-barrel plunger is assembled with a dual-barrel syringe. The dual-barrel plunger preferably includes a first plunger disposed in a first fluid chamber of a first syringe barrel and a second plunger disposed in a second fluid chamber of a second syringe barrel.

[0145] In one embodiment, the end cap may be removably fixed to the distal end of the dual-barrel syringe to cover the first and second fluid dispensing openings located at the distal ends of the first and second syringe barrels, respectively. In one embodiment, the end cap has at least one end cap opening.

[0146] In one embodiment, a gas-permeable barrier is disposed within the end cap and is located between at least one end cap opening and a first and second fluid dispensing opening located at the distal ends of the first and second syringe barrels, respectively. The gas-permeable barrier is permeable to sterile gases and impermeable to fluid materials, allowing sterile gases to pass through the first and second fluid dispensing openings, while preventing first and second portions of fluid materials from passing through the first and second fluid dispensing openings and / or the gas-permeable barrier.

[0147] In one embodiment, the end cap preferably includes a central hub, which engages with the distal end wall of the dual-barrel syringe to form an airtight seal between the end cap hub and the distal end wall of the dual-barrel syringe.

[0148] In one embodiment, the central hub of the end cap has a proximal end that is open to receive a first fluid dispensing opening and a second fluid dispensing opening, and a distal end that is closed by a distal end wall containing at least one end cap opening.

[0149] In one embodiment, the end cap includes at least one radially extending projection that extends outward from the outer surface of the central hub of the end cap.

[0150] In one embodiment, the dual-barrel syringe preferably includes at least one retaining flange protruding from the distal end wall of the dual-barrel syringe, the at least one retaining flange configured to engage with at least one radially extending projection of the end cap in order to releasably secure the end cap to the distal end wall of the dual-barrel syringe.

[0151] In one embodiment, the first syringe barrel preferably has a cylindrical outer wall that surrounds the first fluid chamber and extends to the distal end of the first syringe barrel.

[0152] In one embodiment, at least one first ventilation opening is formed in the cylindrical outer wall of the first syringe barrel.

[0153] A first one-way plunger stopper may be formed on the inner surface of the cylindrical outer wall of the first syringe barrel. The first one-way plunger stopper may be located between at least one first vent and the distal end of the first syringe barrel.

[0154] In one embodiment, at least one second ventilation opening is formed in the cylindrical outer wall of the second syringe barrel.

[0155] A second one-way plunger stopper may be formed on the inner surface of the cylindrical outer wall of the second syringe barrel. The second one-way plunger stopper may be located between at least one second vent of the second syringe barrel and the distal end of the second syringe barrel.

[0156] In one embodiment, the first plunger preferably includes a first plunger head located at the distal end of the first plunger. In one embodiment, the first plunger head is in contact with a first unidirectional plunger stopper and is located between at least one first vent and the distal end of the first syringe barrel.

[0157] In one embodiment, the second plunger preferably includes a second plunger head located at the distal end of the second plunger. In one embodiment, the second plunger head is in contact with a second unidirectional plunger stopper and is located between at least one second vent and the distal end of the second syringe barrel.

[0158] In one embodiment, an enclosure (e.g., syringe, vial) configured to be filled with a fluid material (e.g., liquid, silicone-based topical skin adhesive) is gas-permeable, allowing sterile gases (e.g., ethylene oxide) to flow into the enclosure, while maintaining liquid-sealing capabilities to prevent leakage of the fluid material contained within the enclosure. The enclosure may be made of polymer material and / or glass.

[0159] In one embodiment, the enclosure has one or more walls and one or more apertures formed in at least one of the walls. In one embodiment, at least one of the apertures is filled with a gas-permeable barrier (e.g., a gas-permeable plug, a gas-permeable block, a gas-permeable seal) which allows a sterilizing gas to pass through the gas-permeable barrier to sterilize the contents of the enclosure (e.g., a fluid material) while preventing the contents of the enclosure from leaking out of the enclosure.

[0160] In one embodiment, the enclosure for the fluid material has a plurality of apertures, each aperture being filled with a gas-permeable mass.

[0161] In one embodiment, the gas-permeable mass is permeable to sterilization gases and impermeable to fluid materials (e.g., liquids, fluid topical skin adhesives).

[0162] In one embodiment, an enclosure for a liquid composition is configured to allow gas sterilization. The enclosure has one or more apertures which can be formed anywhere on the enclosure. One or more apertures are preferably filled with a porous, curable composition that is permeable to sterilization gas. The gas-permeable composition has a porosity high enough to allow the sterilization gas to enter and exit during sterilization, but low enough to prevent leakage of the liquid stored in the enclosure.

[0163] In one embodiment, each aperture formed in the enclosure has a diameter of about 1 to 5 mm. A gas-permeable barrier preferably seals the apertures having a diameter of 1 to 5 mm. In one embodiment, the gas-permeable barrier preferably bonds to the enclosure within each aperture.

[0164] In one embodiment, the aperture may be filled with a curable composition having a liquid state, an uncured state, or a partially cured state. After being placed in the aperture, the curable composition may be cured to form a porous gas permeable barrier, plug, body, and / or seal, which allows a sterilizing gas (e.g., ethylene oxide) to pass through to sterilize the inside of the enclosure, while preventing the fluid material placed inside the enclosure from leaking out of the enclosure.

[0165] In one embodiment, the enclosure may include a syringe barrel, a distal end wall of the syringe barrel, a plunger, a dispensing tip, and an end cap that closes the dispensing opening of the dispensing tip. One or more of the above-described apertures may be formed in any one of the syringe barrel, the distal end wall of the syringe barrel, the plunger, the dispensing tip, and the end cap, and each aperture may be filled with one of the gas permeable barriers, plugs, bodies, and / or seals disclosed herein.

[0166] In one embodiment, the formulation used to form a gas permeable barrier is preferably porous and curable, and can reliably block and / or seal holes without affecting the stability of the fluid material (e.g., silicone-based topical skin adhesive) contained within the enclosure.

[0167] In one embodiment, one or more of the apertures may have an asymmetric shape and / or cross-section, and the formulation used to form a gas permeable barrier (e.g., seal, plug) may be introduced into the aperture in an uncured state so as to conform to the shape of the aperture before curing. After complete curing, the gas permeable barrier preferably conforms to the unique shape of the aperture.

[0168] In one embodiment, a system for fabricating a gas-permeable enclosure may include a sacrificial sleeve / cylinder that can be inserted into an enclosure (e.g., a syringe barrel) while introducing a compound used to form a gas-permeable seal within one or more apertures formed in the enclosure. In one embodiment, the sacrificial sleeve / cylinder remains positioned inside the enclosure while the compound used to form the gas-permeable seal is curing. After the compound used to form the gas-permeable seal has cured, the sacrificial sleeve / cylinder can be removed from the enclosure. The sacrificial sleeve / cylinder can function as a frame that shapes the gas-permeable seal, resulting in a smooth surface between the inner surface of the enclosure containing one or more apertures and the surface of the gas-permeable seal filling one or more apertures.

[0169] Cyanoacrylate-based skin closure systems are often used as topical skin adhesives to close wounds, but cyanoacrylate adhesives are relatively inflexible and have an elasticity of less than 1%. When wounds closed with cyanoacrylate adhesives are placed on moving body parts (e.g., knees, wrists, elbows) and stretched, the resulting distribution of stress effects can adversely affect the performance and durability of the wound closure.

[0170] Silicone-based topical skin adhesives have proven far more effective in sealing wounds on moving body parts. The retention force between silicone-based adhesives and the skin is equal to or better than the results that can be achieved when using cyanoacrylate-based skin closure products. Silicone-based topical skin adhesives can be stretched up to 160% of their original length and can fully recover to their original dimensions. When silicone-based topical skin adhesives are combined with anisotropic meshes, this combination can be used to optimize stress distribution and improve performance on human skin compared to relatively inelastic cyanoacrylate-based systems.

[0171] In one embodiment, the fluid material dispensed from a gas-sterilizable syringe preferably includes a silicone-based topical skin adhesive that can be used to close and / or seal wounds, including wounds located on a movable body part.

[0172] Heat sterilization methods used to sterilize cyanoacrylate-based skin closure products are not suitable for silicone-based topical skin adhesives. Therefore, improved systems, devices, and methods are needed for sterilizing devices (e.g., syringes) used to dispense silicone-based topical skin adhesives.

[0173] In one embodiment, the present patent application discloses a system, device, and method for enabling a sterilization gas (e.g., ethylene oxide) to sterilize a fluid material (e.g., a silicone topical skin adhesive) while the fluid material is contained in a gas-sterilizable syringe.

[0174] In one embodiment, a gas-sterilizable syringe preferably includes an enclosure (e.g., a syringe barrel) having walls defining a fluid chamber configured to receive a fluid material (e.g., a silicone-based topical skin adhesive, a component of a topical skin adhesive). In one embodiment, the enclosure preferably includes a movable plunger for dispensing the fluid material.

[0175] In one embodiment, the distal end of the enclosure includes a dispensing opening for extruding a fluid material from the distal end of a gas-sterilizable syringe. In one embodiment, an end cap may be fixed to the distal end of the enclosure to cover the dispensing opening. The end cap preferably has one or more end cap openings. A gas-permeable barrier (e.g., a plug, pack, or body) is preferably disposed between the end cap and the dispensing opening of the enclosure. The gas-permeable barrier is permeable to gases (e.g., sterilization gases) and impermeable to liquids (e.g., silicone-based topical skin adhesives).

[0176] In one embodiment, during the sterilization procedure, a sterilization gas (e.g., ethylene oxide) passes through the end cap opening, the gas permeable barrier, and the dispensing opening to sterilize the syringe, enclosure, fluid chamber, and the fluid material disposed within the fluid chamber of the enclosure.

[0177] In certain embodiments, the gas permeable barrier may be made from one or more of the following materials: silicone materials, including room temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), and high viscosity rubber (HCR).

[0178] In one embodiment, the gas permeable barrier includes a closed-cell structure having voids and / or porosity (i.e., closed-cell porosity). In one embodiment, the gas permeable barrier (e.g., a gas permeable plug) may be molded or die-cut.

[0179] In one embodiment, the gas-sterilizable syringe may include a double-barrel syringe, and the plunger may include a double-barrel plunger.

[0180] In one embodiment, a gas-sterilizable syringe may include a double-barrel syringe containing a two-component polymer material, with a first portion disposed in a first syringe barrel and a second portion disposed in a second syringe barrel. The gas-sterilizable syringe allows for sterilization of the two portions of the polymer material before the two portions are extruded from the syringe.

[0181] In one embodiment, a gas-sterilizable syringe may include a mixer (e.g., a static mixer, a mixing tip) configured to mix two parts of a fluid polymer composition together and apply the mixed polymer material to various locations on the human body.

[0182] In one embodiment, a gas-sterilizable syringe may include a plunger that is perforated to allow sterilization gas to flow around the plunger and into the fluid chamber of the syringe barrel. In one embodiment, the plunger may have a plunger head, the plunger head including a gas-permeable plunger seal, which allows sterilization gas to flow through the gas-permeable plunger seal into the fluid chamber of the syringe barrel. The gas-permeable plunger seal has a porosity high enough to allow sterilization gas (e.g., ethylene oxide) to flow through the plunger seal, but low enough to prevent fluid materials (e.g., silicone-based topical skin adhesives) from passing through the plunger seal.

[0183] In one embodiment, a gas-sterilizable syringe having a double-barrel plunger may include a first gas-permeable plunger seal located at the distal end of the first plunger and a second gas-permeable plunger seal located at the distal end of the second plunger.

[0184] In one embodiment, a gas-permeable barrier (e.g., a gas-permeable plug, a gas-permeable pack) disposed within the end cap and / or a gas-permeable plunger seal fixable to the distal end of each plunger mainly has closed-cell porosity.

[0185] In one embodiment, the gas permeable barriers and gas permeable plunger seals disclosed herein may also be referred to as gas permeable plugs, gas permeable packs, gas permeable bodies, gas permeable masses, gas permeable membranes, gas permeable layers, and / or gas permeable diaphragms.

[0186] In one embodiment, the gas permeable barrier disposed within the end cap and / or the gas permeable plunger seal located at the distal end of the plunger can be made from various silicone rubber materials having a porosity range of 1% to 90%, more preferably 5% to 80%, of the total volume, and mainly having closed-cell porosity.

[0187] In one embodiment, a gas-permeable barrier disposed within the end cap and / or a gas-permeable plunger seal located at the distal end of the plunger are made of a material that does not chemically react with any component of the fluid material (e.g., silicone-based topical skin adhesive) contained in a gas-sterilizable syringe while sealing the fluid material in the syringe during storage.

[0188] In one embodiment, the gas-permeable barrier and / or gas-permeable plunger seal may be made from a porous silicone material having a Shore A hardness grade of 10 to 50.

[0189] In one embodiment, the porosity of a silicone polymer used to form a gas-permeable seal can be generated during curing using an in-situ gas generation method.

[0190] In one embodiment, the gas-permeable seal may be made using a commercially available silicone RTV foam, thereby the formulation may be modified to adjust the porosity level to optimize results when used with a gas-sterilizable syringe.

[0191] In one embodiment, the gas permeable barrier and / or gas permeable plunger seal may be molded or die-cut. In one embodiment, the gas permeable barrier disposed within the end cap may be die-cut from a larger porous silicone rubber sheet. In one embodiment, the gas permeable plunger seal may be manufactured using a molding process.

[0192] In other embodiments, the gas-permeable barrier may be made using other gas-permeable materials such as rubber and / or polymer materials.

[0193] In one embodiment, the gas-permeable seal is made from a material suitable for the contents of the syringe. Examples of these materials include, but are not limited to, silicone-polyethylene, silicone-acrylic, or silicone-polyurethane copolymers, which can be formed into the shape of the gas-permeable sealing components disclosed herein.

[0194] In one embodiment, a gas-sterilizable syringe may be filled at the end cap side of the enclosure. Filling via the end cap side of the enclosure may also be referred to as cap-side filling. In one embodiment, a fluid material (e.g., a silicone-based topical skin adhesive) is loaded into the syringe through one or more dispensing openings located at the distal end of the enclosure (e.g., the distal end of a double-barrel syringe).

[0195] In one embodiment of the filling method, a non-ventilated double-barrel plunger can be fully inserted into a double-barrel syringe such that the plunger head is located at the closed distal end of the syringe barrel. In one embodiment, the fluid material is guided to a dispensing opening located at the distal end of the syringe barrel. As the fluid material fills the fluid chamber of the syringe barrel, the fluid pressure created by the fluid material moves the non-ventilated plunger toward the proximal end of the syringe (i.e., retracts it). The final resting position of the non-ventilated double-barrel plunger depends on the volume of fluid material guided into the fluid chamber of the syringe barrel. The cap-side filling method described above minimizes the volume of ambient air trapped within the syringe barrel. Once the syringe is filled to a pre-selected filling volume, an end cap having one or more end cap openings and a gas-permeable barrier disposed within the end cap are fixed to the distal end of the syringe barrel.

[0196] During the sterilization procedure, the sterilization gas preferably passes through the end cap opening of the end cap, through the gas permeable barrier, through the dispensing opening, and into the fluid chamber of each syringe barrel, sterilizing the inside of the syringe barrel, the fluid chamber, and the fluid material contained within the syringe barrel.

[0197] In one embodiment of the filling method, cap-side syringe filling can be achieved by first positioning the piston at the closed distal end of the syringe barrel of a double-barrel syringe. A vented plunger is preferably advanced into the open proximal end of the syringe barrel and moved toward the closed distal end of the syringe barrel until the distal end of the plunger engages with the piston. The piston creates a proper seal with the inner surface of the syringe barrel, and the vented plunger is freely inserted behind the piston. As the fluid material fills the fluid chamber of the syringe barrel, the fluid pressure created as the compound enters the syringe from the cap side causes the piston and the vented plunger to move proximal (i.e., retract) to a final resting position, which depends on a pre-selected volume of fluid material introduced into the syringe. The larger the volume of fluid material loaded into each syringe barrel, the greater the proximal movement of the plunger relative to the distal end of the syringe barrel. Once a pre-selected volume of the fluid material is achieved (i.e., after filling), an end cap with one or more end cap openings and a gas-permeable barrier are fixed to the distal end of the syringe barrel.

[0198] During the sterilization procedure, the sterilization gas preferably passes through the end cap opening in the end cap, through the gas permeable barrier, through the dispensing opening, and into the fluid chamber of the syringe barrel, sterilizing the inside of the syringe barrel and its contents.

[0199] In the case of a gas-sterilizable syringe having a ventilated plunger, the sterilization gas preferably flows through the ventilated plunger into the fluid chamber of the enclosure (e.g., a double-barrel syringe) to sterilize the fluid chamber and the fluid material disposed within it.

[0200] In one embodiment, a gas-sterilizable syringe may be filled through the proximal open end of the syringe barrel. This method may be referred to as plunger-side filling. In one embodiment, during the plunger-side filling method, before filling the syringe barrel with the fluid material, an end cap having one or more end cap openings and a gas-permeable barrier are fixed to the end cap side of the syringe barrel. In one embodiment, the fluid material is introduced into the open end of the syringe barrel to fill the syringe barrel through the open plunger side. A plunger is then inserted into the open end of the syringe barrel to create a suitable seal for the fluid material filling the syringe barrel. This compressible plunger is used to expel ambient air that remains trapped inside the filled syringe barrel.

[0201] In one embodiment, a plunger-side filling method can be used to improve efficiency and minimize costs. In one embodiment, plunger-side filling allows high-throughput automated filling equipment to be used to fill syringes with a fluid material. The plunger-side filling method also allows the use of syringes having the same external footprint, thereby allowing the system to be controlled to provide multiple different filling volumes. By utilizing syringes with the same external footprint, the operator can also use a single shared blister package for syringes with different filling volumes.

[0202] In one embodiment, to achieve the efficiency described above, the plunger-side syringe filling method uses a non-ventilated plunger inserted into a ventilated syringe barrel having a unidirectional plunger retaining element and precisely positioned syringe barrel vents. When using a known filling volume that does not exceed the available filling volume of the syringe, the unidirectional plunger retaining element and syringe barrel vents are positioned to allow ambient air to be effectively expelled from the filled syringe barrel.

[0203] In one embodiment, after the plunger side of the syringe barrel is filled, the plunger is advanced distally toward the distal end of the syringe barrel to expel air from the syringe barrel through a syringe barrel vent. After the plunger head has effectively expelled air from the syringe barrel, the syringe barrel vent is positioned along the length of each syringe barrel, preferably close to the leading edge of the plunger head, depending on a pre-selected volume of the fluid material used to fill the syringe barrel.

[0204] In one embodiment, the syringe barrel vent also preferably plays a secondary function that assists the sterilization process by creating an additional pathway for the entry and exit of sterilization gas to the syringe barrel in order to sterilize the fluid material contained within the syringe barrel.

[0205] In one embodiment, the one-way plunger retaining element is preferably formed in the inner diameter of the syringe barrel such that when the plunger is inserted into the filled syringe, the plunger can easily move over the one-way plunger retaining element as it moves distally, but when the plunger head moves distally beyond the one-way plunger retaining element, the plunger has a structure (e.g., a radially extending projection) that prevents the plunger from easily retracting toward the proximal end of the syringe by contacting the one-way plunger retaining element. In one embodiment, when the plunger head moves beyond the one-way plunger retaining element, excessive force is required to retract the plunger.

[0206] By positioning the syringe barrel vent hole precisely relative to the location of the one-way plunger fastening element and according to the volume of fluid material used to fill the syringe barrel, the plunger head ensures that the syringe barrel vent hole is isolated from the fluid material contained within the syringe barrel.

[0207] The precise locations of the syringe barrel vents and one-way stoppers can be modified within a standard set of syringe barrels to accommodate a number of unique filling volumes. Each unique filling volume preferably generates its own unique syringe design, but all designs preferably fit within one general-purpose set of syringe barrels having constant external dimensions. [Brief explanation of the drawing]

[0208] [Figure 1] This is a schematic diagram of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a syringe barrel having a distal end wall, a dispensing tip, and an end cap, and a syringe plunger, and having a plurality of micro-apertures formed internally to enable gas sterilization of the syringe. [Figure 2] This patent application describes a method for producing a gas-sterilizable syringe having multiple micro-apertures to enable gas sterilization of the gas-sterilizable syringe, according to one embodiment of this patent application. [Figure 3A] This is a schematic diagram of a gas-sterilizable syringe, including a syringe barrel and a syringe plunger, according to one embodiment of the present patent application, wherein the syringe barrel has a plurality of micro-apertures formed internally to enable gas sterilization of the gas-sterilizable syringe. [Figure 3B] Figure 3A shows a gas-sterilizable syringe with the end cap removed and the syringe plunger moved to a distal location to the syringe plunger location shown in Figure 3A. [Figure 4]A cross-sectional view of a syringe barrel for a gas-sterilizable syringe according to one embodiment of the present patent application, wherein the syringe barrel includes an outer wall in which a plurality of blind micro-apertures are formed to enable gas sterilization of the gas-sterilizable syringe while preventing viscous fluid material from leaking through the blind micro-apertures. [Figure 5A] A schematic diagram of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a syringe barrel formed with a plurality of micro-apertures to enable gas sterilization of the gas-sterilizable syringe, and a protective sleeve slidable across the outer surface of the syringe barrel to selectively cover the plurality of micro-apertures. [Figure 5B] Figure 5A shows a gas-sterilizable syringe according to one embodiment of this patent application, in which a protective sleeve is in an extended position to cover a plurality of micro-apertures formed within the syringe barrel. [Figure 6] This is a schematic diagram of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a syringe barrel and a dispensing tip having a plurality of microapertures formed thereon, and further comprising a first microporous sleeve covering the microapertures formed on the syringe barrel and a second microporous sleeve covering the microapertures formed on the dispensing tip. [Figure 7] This is a schematic diagram of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a syringe barrel, a dispensing tip having a plurality of microapertures formed thereon, and a microporous sleeve covering the inner surfaces of the syringe barrel and the dispensing tip. [Figure 8] This is a schematic diagram of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a syringe barrel, a distal end wall that partially closes the distal end of the syringe barrel, a dispensing tip, an end cap that covers the distal end of the dispensing tip, and a syringe plunger having a piston, and including a plurality of microapertures formed on the syringe barrel, distal end wall, end cap, and piston, each covered by a microporous sleeve. [Figure 9]This is a schematic diagram of a gas-sterilizable syringe system according to one embodiment of the present patent application, comprising a first syringe barrel having a plurality of micro-apertures formed thereon, and a second syringe barrel having a plurality of micro-apertures formed inside to enable gas sterilization of the first and second syringe barrels. [Figure 10A] This is a schematic diagram of a gas-sterilizable syringe subassembly according to one embodiment of the present patent application, comprising a syringe barrel having a distal end wall, a dispensing tip, and an end cap, and a syringe plunger, and having a plurality of apertures formed internally. [Figure 10B] A schematic diagram of a gas-sterilizable syringe, comprising the subassembly shown in Figure 10A, according to one embodiment of the present patent application, and having a gas-permeable barrier that fills an aperture to enable gas sterilization of the gas-sterilizable syringe. [Figure 11A] This is a schematic diagram of a gas-sterilizable syringe subassembly including a syringe barrel having a plurality of apertures formed internally, according to one embodiment of the present patent application. [Figure 11B] Figure 11A shows a syringe barrel having a gas-permeable barrier that fills an aperture to enable gas sterilization of a gas-sterilizable syringe, according to one embodiment of this patent application. [Figure 12] This patent application describes a method for producing a gas-sterilizable syringe having an aperture and a gas-permeable barrier that fills the aperture to enable gas sterilization of the gas-sterilizable syringe. [Figure 13] This is an exploded view of a gas-sterilizable syringe according to one embodiment of the present patent application, which includes a double-barrel syringe, a double-barrel plunger, an end cap having an end cap opening, and a gas-permeable barrier. [Figure 14] Figure 13 shows a top view of the gas permeable barrier. [Figure 15]This document shows a distal end view of a gas-sterilizable syringe, which includes a double-barrel syringe, an end cap having an end cap opening fixed to the distal end of the double-barrel syringe, and a gas-permeable barrier disposed within the end cap, according to one embodiment of this patent application. [Figure 16A] This is an exploded view of a gas-sterilizable syringe according to one embodiment of the present patent application, which includes a double-barrel syringe, a double-barrel plunger having a first plunger and a second plunger, plunger seals fixed to the distal ends of the first and second plungers respectively, and an end cap that can cover and fix the distal end of the double-barrel syringe. [Figure 16B] Figure 16A shows a side view of a gas-sterilizable syringe, which is assembled with a double-barrel syringe, a double-barrel plunger having plunger seals fixed to the distal ends of the first and second plungers, and an end cap, and after the syringe barrel has been filled with a fluid material. [Figure 17] This is an exploded view of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising: a double-barrel syringe; an end cap having an end cap opening; a gas-permeable barrier located at the distal end of the double-barrel syringe; a double-barrel plunger having a plunger plunger insertable into the double-barrel syringe; a first gas-permeable plunger seal and a second gas-permeable plunger seal fixable to the distal ends of the first and second plungers, respectively; and a mixing and dispensing tip. [Figure 18A] This is a perspective view of a gas-sterilizable syringe according to one embodiment of the present patent application, comprising a double-barrel syringe, a double-barrel plunger, and an end cap having an end cap opening. [Figure 18B] Figure 18A is a front view of a gas-sterilizable syringe. [Figure 19]Figures 18A and 18B show exploded views of a gas-sterilizable syringe, according to one embodiment of this patent application, which includes a double-barrel syringe, a double-barrel plunger, an end cap having an end cap opening, and a gas-permeable barrier configured to be disposed within the end cap. [Figure 20] Figure 19 is an exploded view of a gas-sterilizable syringe. [Figure 21A] Figure 19 shows a perspective view of the distal end of a double-barrel plunger, including a first plunger and a second plunger. [Figure 21B] Figure 21A is a perspective view of the double barrel plunger shown. [Figure 22A] Figure 21B shows a magnified view of the distal ends of the first and second plungers of the double-barrel plunger. [Figure 22B] Figures 21A and 22A are perspective views of the distal ends of the first and second plungers of the double-barrel plunger shown. [Figure 23] Figure 19 shows a cross-sectional view of a double-barrel syringe, including a first syringe barrel and a second syringe barrel. [Figure 24] Figure 23 is an enlarged view of the central section of the first syringe barrel. [Figure 25] Figure 19 is a cross-sectional view of a double-barrel syringe. [Figure 26] Figure 19 is a cross-sectional view of the double barrel plunger shown. [Figure 27] Figure 18B is a cross-sectional view of a gas-sterilizable syringe. [Figure 28A] Figure 18B is a magnified view of the central section of a gas-sterilizable syringe. [Figure 28B] This is a cross-sectional view of the central section of the first syringe barrel of a gas-sterilizable syringe according to one embodiment of this patent application. [Figure 29A] Figures 18A and 18B are perspective views of the end cap of a gas-sterilizable syringe. [Figure 29B] Figure 29B is another perspective view of the end cap. [Figure 29C] Figures 29A and 29B are front views of the end cap. [Figure 29D] Figures 29A to 29C are top views of the end caps. [Figure 30] Figure 19 is a cross-sectional view of the end cap and gas permeable barrier shown. [Figure 31] Figure 30 shows an end cap in which a gas permeable barrier is disposed inside the end cap, according to one embodiment of this patent application. [Figure 32] The image shows a cross-sectional view of the distal end of a gas-sterilizable syringe, which includes a double-barrel syringe, a double-barrel plunger, an end cap fixed to the distal end of the double-barrel syringe, and a gas-permeable barrier, according to one embodiment of this patent application. [Figure 33] The image shows a top view of a gas-sterilizable syringe subassembly, including a double-barrel syringe and a double-barrel plunger, according to one embodiment of this patent application. [Figure 34A] Figure 33 shows a perspective view of a multifunctional connector that covers and secures the distal end of a double-barrel syringe, according to one embodiment of this patent application. [Figure 34B] Figure 34A shows a distal end view of the multi-functional connector. [Figure 35] Figures 34A and 34B show an exploded view of a multifunctional connector, a first gas permeable barrier and a second gas permeable barrier that can be inserted into the D-shaped opening of the multifunctional connector, and an end cap that can be fixed to the threaded post of the multifunctional connector, according to one embodiment of this patent application. [Figure 36] This figure shows the end cap of Figure 35 covering and securing the male threaded post of the multi-functional connector of Figure 35. [Figure 37] Figure 36 shows a perspective view of multiple gas-sterilizable syringes, each having a multi-functional connector and end cap fixed to its distal end. [Figure 38]This shows a side view of the mixing and dispensing tip of a gas-sterilizable syringe according to one embodiment of this patent application. [Figure 39] Figure 38 shows a mixing and dispensing tip fixed to the distal end of a gas-sterilizable syringe, according to one embodiment of this patent application. [Figure 40] The distal end view of a multifunctional connector for a gas-permeable syringe having a first D-shaped opening and a second D-shaped opening adapted to receive a gas-permeable barrier is shown, according to one embodiment of the present patent application. [Figure 41] A distal end view of a prior art connector for a double-barrel syringe is shown. [Modes for carrying out the invention]

[0209] Referring to Figure 1, in one embodiment, the gas-sterilizable syringe 100 preferably includes a syringe barrel 102 and a syringe plunger 104 configured to be assembled with the syringe barrel. The syringe barrel 102 preferably has a fluid chamber 105 configured to receive a fluid material, such as a precursor or component of a tissue adhesive. In one embodiment, the fluid material is a viscous fluid material having a relatively high viscosity of about 1,000 to 100,000 centipoise, more preferably about 2,000 to 75,000 centipoise, and even more preferably about 30,000 to 60,000 centipoise. In one embodiment, the syringe plunger 104 may be pushed down distally in the direction DIR1 to dispense the viscous fluid material. The gas-sterilizable syringe 100 may be made from a variety of materials, including polymer materials, glass, and rubber, and / or combinations of the aforementioned materials.

[0210] In one embodiment, the viscous fluid material includes, or may be, a precursor of a two-component silicone adhesive formulation, as disclosed in U.S. Patent Application Publication No. 16 / 885,361 filed May 28, 2020 (Agent Reference No. ETH6070USNP1), U.S. Patent Application Publication No. 17 / 327,940 filed May 24, 2021 (Agent Reference No. ETH6070USCIP1), U.S. Patent Application Publication No. 16 / 885,366 filed May 28, 2021 (Agent Reference No. ETH6084USNP1), and U.S. Patent Application Publication No. 17 / 327,952 filed May 24, 2020 (Agent Reference No. ETH6084USCIP1), the disclosures of which are incorporated herein by reference.

[0211] In one embodiment, the syringe barrel 102 preferably has an open proximal end 106 and a distal end 108 partially closed by a distal end wall 110. The gas-sterilizable syringe 100 preferably includes a dispensing tip 112 projecting distally from the distal end wall 110. The dispensing tip 112 has a conduit 114 that provides a flow path for dispensing a fluid material disposed within the fluid chamber 105 of the syringe barrel 102. The distal end opening of the conduit 114 may be covered by an end cap 116. The end cap 116 can cover the distal end of the dispensing tip 112 during shipping and storage. The end cap 116 may be removed from the distal end of the dispensing tip 112 to dispense the fluid material.

[0212] In one embodiment, the syringe plunger 104 preferably includes a piston 118 disposed within the fluid chamber 105 of the syringe barrel 102. The piston 118 preferably has an outer circumference that engages with the inner surface of the syringe barrel 102 to form a seal between the piston and the inner surface of the syringe barrel. The piston 118 may be made of rubber or polymer material. The plunger 104 preferably includes a plunger stem 120 having a distal end fixed to the proximal side of the piston 118. In one embodiment, the plunger 104 preferably includes a thumb tab 122 fixed to the proximal end of the plunger stem 120. The thumb tab 122 may be pushed distally, indicated by DIR1, to force the piston 118 to slide distally toward the distal end wall 110 of the syringe barrel 102. In one embodiment, with the end cap 116 removed, when the thumb tab 122 is pushed down distally in the DIR1 direction, the fluid material pre-loaded in the fluid chamber 105 of the syringe barrel 102 can be forced downstream and flow into the conduit 114 of the dispensing tip 110 so as to be dispensed from the opening at the distal end of the dispensing tip 112.

[0213] In one embodiment, the syringe barrel 102 preferably has an outer wall 124, and a plurality of micro-apertures 126 may be formed in the outer wall 124 of the syringe barrel 102 (e.g., by perforation, laser perforation, mechanical perforation). The micro-apertures 126 can be formed by using a laser device that laser-perforates small openings. In one embodiment, the syringe barrel 102 has a length extending along a longitudinal axis A1, and the micro-apertures 126 may extend along an axis A2 perpendicular to the longitudinal axis A1 of the syringe barrel 102. In one embodiment, one or more micro-apertures 128 may extend through the outer wall 124 of the syringe barrel 102 along an axis A3 that is oblique to and / or not perpendicular to the longitudinal axis A1.

[0214] In one embodiment, one or more microapertures 130 may extend through the piston 118 of the syringe plunger 104.

[0215] In one embodiment, one or more microapertures 132 may be formed on the distal end wall 110 of the syringe barrel 102. The microapertures 132 formed on the distal end wall 110 may extend along axes that are parallel to the longitudinal axis A1 of the syringe barrel 102. However, in other embodiments, the microapertures 132 formed on the distal end wall 110 may extend along axes that define an angle with respect to the longitudinal axis A1 of the syringe barrel 102.

[0216] In one embodiment, one or more of the micro-apertures 130 extending through the piston 118 may be positioned within and / or aligned with the plunger stem 120 of the plunger 104 extending between the thumb tab 122 and the piston 118.

[0217] In one embodiment, one or more microapertures 134 may be formed within an end cap 116 that covers and secures the distal end of the dispensing tip 112. In one embodiment, the end cap 116 may have microapertures 134 extending along axes that are parallel to the longitudinal axis A1 of the syringe barrel 102. In one embodiment, the end cap 116 may have one or more microapertures 136 extending along axes that are not parallel to the longitudinal axis A1 of the syringe barrel 102 (e.g., oblique).

[0218] Microapers disclosed herein can be formed using a variety of techniques and methods. Referring to Figure 2, in one embodiment, a laser device 125 can be utilized to form a microaperture 126 in the outer wall 124 of the syringe barrel 102. In one embodiment, the laser device 125 preferably generates a laser beam 135 that contacts the outer wall 124 of the syringe barrel 102 to laser-perforate a microaperture 126 that extends entirely through the outer wall 124 (i.e., from the outer surface 138 to the inner surface 140 of the outer wall 124). In one embodiment, the laser device 125 may be configured to form one or more microapertures perpendicular to the longitudinal axis A1 of the syringe barrel. The laser device 125 may also be programmed to form one or more microapertures 128 that are parallel, oblique, and / or not perpendicular to the longitudinal axis A1 of the syringe barrel 102.

[0219] In one embodiment, the laser device 125 may be used to form one or more microapertures 130 in the piston 118 of the plunger 104, one or more microapertures 132 in the distal end wall 110 of the syringe barrel 102, and / or one or more microapertures 134, 136 in the end cap 116 that covers and secures the distal end of the dispensing tip 112. The laser device may also be used to laser-perforate microapertures in the dispensing tip 112.

[0220] Other methods may be used to form microapertures on one or more components of a gas-sterilizable syringe, including the use of a mechanical drill, a heated probe, and a water jet.

[0221] Referring to Figure 3A, in one embodiment, the syringe 200 preferably includes a syringe barrel 202 having an outer wall 224 with an outer surface 238 and an inner surface 240. The syringe barrel 202 preferably has an open proximal end 206 and a distal end 208 that is at least partially closed by a distal end wall 210. The outer wall 224 of the syringe barrel 202 preferably defines and / or surrounds a fluid chamber 205 configured to receive a viscous fluid material (not shown). The syringe 200 has a distal end wall 210 and a dispensing tip 212 protruding from the distal end wall 210. The distal end of the dispensing tip 212 is covered by an end cap 216 that can be removed for dispensing a viscous fluid material.

[0222] In one embodiment, the syringe barrel 202 preferably has one or more microapertures 226 formed on the outer wall 224 of the syringe barrel 202, extending from the outer surface 238 to the inner surface 240 of the outer wall 224. In one embodiment, one or more microapertures 226 are closer to the proximal end 206 of the syringe barrel 202 than to the distal end 208 of the syringe barrel.

[0223] Referring to Figures 3A and 3B, in one embodiment, positioning one or more micro-apertures 226 closer to the proximal end 206 than to the distal end 208 of the outer wall 226 of the syringe barrel 202 significantly reduces the chance of viscous fluid material leaking through one or more micro-apertures 226 when the plunger 204 is pushed down distally in DIR1. As shown in Figures 3A and 3B, at the start of the procedure for dispensing fluid material (i.e., the position of the plunger 204 shown in Figure 3A), after the end cap 216 (Figure 3A) is removed from the distal end of the dispensing tip 212, the piston 218 is positioned near the proximal end 206 of the outer wall 224 of the syringe barrel 202. When the syringe plunger 204 is pushed down to start the dispensing procedure, the piston 218 moves distally (DIR1) beyond one or more micro-apertures 226 formed in the syringe barrel. As a result, as the dispensing operation progresses, the piston 218 moves beyond the micro-aperture 226 and advances distally into the section of the outer wall 224 that does not have a micro-aperture, thereby providing continuous extrusion of the fluid material while minimizing the possibility of the viscous fluid material leaking through the micro-aperture.

[0224] Referring to Figure 4, in one embodiment, the gas-sterilizable syringe 300 preferably includes a syringe barrel 302 having an outer wall 324 extending along the longitudinal axis A1 of the syringe barrel 302. The outer wall 324 of the syringe barrel 302 preferably includes an outer surface 338 and an inner surface 340 defining a fluid chamber 305 adapted to contain a viscous fluid material 315 to be dispensed during the operation of the syringe 300. In one embodiment, the syringe 300 preferably includes one or more micro-apertures 326 having blind openings formed in the outer wall 324 of the syringe barrel 302. The blind opening of the micro-aperture 326 does not extend all the way through the outer wall 324 and does not reach the inner surface 340 of the outer wall 324, thereby leaving a thin film 335 formed from the outer wall 324 that extends between the closed end of the blind opening of the micro-aperture and the inner surface 340 of the outer wall 324 of the syringe barrel 302.

[0225] In one embodiment, the micro-apertures 326, 328 have an inner diameter ID1 of preferably about 0.1 microns to about 25 microns, more preferably about 1 micron. In one embodiment, the viscous fluid material 315 disposed within the fluid chamber 305 has a viscosity of preferably about 1,000 to 100,000 centipoise, more preferably about 2,000 to 75,000 centipoise, and even more preferably about 30,000 to 60,000 centipoise. As a result, a sterilization gas (e.g., ethylene oxide) can pass through the micro-apertures 326, 328 and membrane 335 to sterilize the inside of the fluid chamber 305, but during dispensing, when the fluid material 315 is under positive pressure, the higher viscosity of the fluid material 315 prevents the fluid material 315 from leaking through the membrane 335 or from leaking through the micro-apertures 326, 328.

[0226] In one embodiment, a first group of micro-apertures 326 having blind openings can extend along their respective axes perpendicular to the longitudinal axis A1 of the syringe barrel 302.

[0227] In one embodiment, a second group of microapertures 328 having blind openings may extend along each axis oblique to the longitudinal axis A1 of the syringe barrel 302 and / or along each axis not perpendicular to the longitudinal axis A1.

[0228] Referring to Figure 5A, in one embodiment, the gas-sterilizable syringe 400 preferably includes a protective sleeve 442 that can move along the syringe barrel between a retracted position (Figure 5A) for sterilizing the syringe and the viscous fluid material loaded in the syringe and an extended position (Figure 5B) for dispensing the viscous fluid material. In one embodiment, the gas-sterilizable syringe 400 preferably includes a syringe barrel 402, a plunger 404, a dispensing tip 412 protruding from the distal end 408 of the syringe barrel 402, and an end cap 416 covering the opening at the distal end of the dispensing tip 412. In one embodiment, the syringe 400 preferably includes one or more micro-apertures 426 formed on the outer wall 424 of the syringe barrel 402 and extending from the outer surface 438 to the inner surface 440 of the syringe barrel 402. One or more microapertures 426 may have axes perpendicular to the longitudinal axis A1 of the syringe barrel 402 and / or non-perpendicular axes (e.g., extending obliquely).

[0229] Referring to Figures 5A and 5B, in one embodiment, a protective sleeve 442, which may be made of a non-porous material, is fitted to slide on the outer surface 438 of the outer wall 424 of the syringe barrel 402 between a retracted position shown in Figure 5A and an extended position shown in Figure 5B. In the retracted position shown in Figure 5A, the protective sleeve 442 does not cover one or more micro-apertures 426 so that a sterilization gas (e.g., ethylene oxide) can be used to sterilize the syringe 400 and the viscous fluid material (not shown) disposed in the fluid chamber 405 of the syringe barrel 402. When the protective sleeve 442 is retracted (Figure 5A), the sterilization gas can pass through the micro-apertures 426 to sterilize the syringe 400 containing the viscous fluid material in the fluid chamber 405.

[0230] In the position shown in Figure 5B, the protective sleeve 442 is moved to an extended position to cover one or more micro-apertures 426 formed in the outer wall 424 of the syringe barrel 402. In one embodiment, the protective sleeve 442 is provided on the outer wall 424 of the syringe barrel 402 so that it can slide over one or more micro-apertures 426 after sterilization and before dispensing the fluid material to seal the micro-apertures 426 and prevent leakage through the micro-apertures as the fluid material is dispensed from the syringe 400. When the fluid material (not shown) is under positive pressure during the dispensing operation, the extended protective sleeve 442 (Figure 5B) prevents the fluid material from leaking out of the micro-apertures 426.

[0231] Referring to Figure 6, in one embodiment, a gas-sterilizable syringe 500 preferably includes a syringe barrel 502 defining a fluid chamber 505 adapted to receive a fluid material (e.g., a precursor of tissue adhesive), a plunger 504 having a piston 518, a dispensing tip 512, and an end cap 516 covering the dispensing opening at the distal end of the dispensing tip 512. In one embodiment, a plurality of micro-apertures 526 are defined in the outer wall 524 of the syringe barrel 502. A gas-permeable barrier, such as a microporous sleeve 544 (e.g., a TYVEK® sleeve), which is impermeable to the fluid material stored in the fluid chamber 505 of the syringe barrel 502 but permeable to a sterilization gas (e.g., ethylene oxide), may be provided on the outer surface 538 of the outer wall 524 of the syringe barrel 502 so as to cover the micro-apertures 526 formed in the outer wall 524 of the syringe barrel.

[0232] In one embodiment, the gas-sterilizable syringe 500 may include additional microapertures formed elsewhere, which are covered by one or more microporous sleeves. In one embodiment, the dispensing tip 512 of the syringe 500 may have one or more internally formed microapertures 546, which are covered by a dispensing tip microporous sleeve 548 that is structurally similar to a microporous sleeve 544 that covers a microaperture 526 formed in the syringe barrel 502.

[0233] The microporous sleeve 548 (e.g., TYVEK® sleeve) is impermeable to the fluid material stored in the fluid chamber 505 of the syringe barrel 502 (to prevent leakage), but permeable to a sterile gas (e.g., ethylene oxide). The microporous sleeve 548 can be wrapped around the outer surface of the dispensing tip 512 to cover a microaperture 526 formed on the outer wall of the dispensing tip. In one embodiment, the microporous material can line the inner surface of the dispensing tip.

[0234] Referring to Figure 7, in one embodiment, the gas-sterilizable syringe 600 preferably includes a syringe barrel 602, a plunger 604, and a dispensing tip 612 protruding from the distal end of the syringe barrel 602. In one embodiment, the syringe 600 preferably includes a plurality of micro-apertures 626 formed in the outer wall 624 of the syringe barrel 602 and extending from the outer surface 638 to the inner surface 640 of the outer wall 624 of the syringe barrel 602. The micro-apertures 626 preferably have fluid communication with the fluid chamber 605 of the syringe barrel 602. In one embodiment, a microporous sleeve 644 (e.g., a TYVEK® sleeve) preferably lining the inner surface 640 of the outer wall 624 of the syringe barrel 602 and covering the micro-apertures 626 extending through the outer wall 624 of the syringe barrel 602. The microporous sleeve 644 preferably defines an inner diameter ID2 that allows the piston 618 of the plunger 604 to slide on the inner surface 645 of the microporous sleeve 644, while preferably maintaining a fluid seal with the inner surface of the microporous sleeve 644. In one embodiment, when the syringe plunger 604 is pushed down in the distal direction DIR1 to dispense a viscous fluid material through the dispensing tip 612, the piston 618 preferably slides on the inner surface 645 of the microporous sleeve 644.

[0235] In one embodiment, the dispensing tip 612 preferably includes a plurality of micro-apertures 644 formed on the outer wall of the dispensing tip 612, which are in fluid communication with the fluid chamber 605 of the syringe barrel 602. In one embodiment, a second microporous sleeve 648 preferably lines the inner surface of the dispensing tip 612 and covers the micro-apertures 644 formed within the dispensing tip 612. The second microporous sleeve 648 is not permeable to the fluid fluid stored in the fluid chamber 605 of the syringe barrel 602, but the second microporous sleeve 644 is permeable to a sterilization gas (e.g., ethylene oxide) that can be used to sterilize the syringe 600 and the fluid fluid disposed in the fluid chamber 605 of the syringe.

[0236] Referring to Figure 8, in one embodiment, the gas-sterilizable syringe 700 preferably includes a syringe barrel 702, a syringe plunger 704 including a piston 718, a dispensing tip 712, and an end cap 716 that selectively covers the opening at the distal end of the dispensing tip 712. The syringe barrel 702 preferably has a proximal end 706 that is open to receive the plunger 704 and a distal end 708 that is partially closed by a distal end wall 710.

[0237] In one embodiment, the micro-aperture 726 is formed on the outer wall 724 of the syringe barrel 702. In one embodiment, the microporous sleeve 744 covers the outer surface 738 of the outer wall 724 of the syringe barrel 702, thereby covering the micro-aperture 726 formed on the outer wall 724 of the syringe barrel 702. The microporous sleeve 744 allows sterilization gas to pass through the micro-aperture 726 to sterilize the syringe 700 and the fluid material disposed within the syringe 700, while preventing the fluid material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-aperture 726.

[0238] In one embodiment, the distal end wall 710 preferably has one or more micro-apertures 732 formed internally. A microporous layer 748 preferably covers the micro-apertures 732 formed in the distal end wall 710. The microporous layer 748 allows sterilization gas to pass through the micro-apertures 732 formed in the distal end wall 710 to sterilize the syringe 700 and the fluid material disposed within the syringe 700, while preventing the fluid material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 732.

[0239] In one embodiment, the end cap 716 has one or more micro-apertures 734 formed inside, and a microporous layer 752 covers one or more micro-apertures 743 within the end cap 716. The microporous layer 752 allows sterilization gas to pass through the micro-apertures 734 formed in the end cap 716 for sterilizing the syringe 700 and the fluid material, while preventing the fluid material disposed in the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 734.

[0240] In one embodiment, the piston 718 of the syringe plunger 704 preferably has one or more micro-apertures 730 formed internally, and a microporous layer 750 covers the one or more micro-apertures 730 formed on the piston 718. The microporous layer 750 allows sterilization gas to pass through the micro-apertures 730 formed on the piston 718 in order to sterilize the syringe 700 and the fluid material, while preventing the fluid material disposed in the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 730 of the piston 718.

[0241] Referring to Figure 9, in one embodiment, the syringe system 800 for dispensing a tissue adhesive precursor may include a first syringe barrel 802A containing a first precursor of a tissue adhesive having a plurality of internally formed microapertures 826A extending from the outer surface to the inner surface of the outer wall 824A of the first syringe barrel 802A.

[0242] In one embodiment, the system 800 preferably includes a second syringe barrel 802B, which contains a second precursor of the tissue adhesive and has a plurality of micro-apertures 826B formed inside. The plurality of micro-apertures 826B extend from the outer surface to the inner surface of the outer wall 824B of the second syringe barrel 802B.

[0243] In one embodiment, the syringe system 800 preferably includes a plunger 804 that allows two fluid materials disposed in the first and second syringe barrels 802A, 802B to be dispensed simultaneously and / or substantially simultaneously from the dispensing tips 812A, 812B of the first and second syringe barrels 802A, 802B. Once dispensed, the first and second precursors are preferably mixed and / or joined together to form a tissue adhesive.

[0244] In one embodiment, one or more of the gas-sterilizable syringes disclosed herein may be sterilized by placing the syringe in a pouch adapted for use during a gas sterilization procedure. The pouch may have one or more non-porous panels (e.g., made from foil and made from a flexible polymer) and one or more porous panels (e.g., made from TYVEK® material) that allow sterilization gas to pass through. The pouch may be sealed to enclose the syringe inside the pouch. After the pouch is sealed, sterilization gas may pass through one or more porous panels of the sealed pouch to sterilize the syringe placed inside the sealed pouch. After sterilization, one or more porous panels maintain the sterile state of the syringe by preventing bacteria and contaminants from passing through the porous panels.

[0245] Referring to Figure 10A, in one embodiment, a gas-sterilizable enclosure 900 (e.g., a gas-sterilizable syringe) preferably includes a syringe barrel 902 and a syringe plunger 904 configured to be assembled with the syringe barrel. The syringe barrel 902 preferably defines a fluid chamber 905 configured to receive a fluid material such as a precursor or component of a tissue adhesive (e.g., a silicone-based topical skin adhesive).

[0246] In one embodiment, the syringe barrel 902 preferably has an open proximal end 906 and a distal end 908 that is at least partially closed by a distal end wall 910. The gas-sterilizable syringe 900 preferably includes a dispensing tip 912 projecting distally from the distal end wall 910. The dispensing tip 912 has a conduit 914 that provides a flow path for dispensing a fluid material (not shown). The fluid material may be disposed within a fluid chamber 905 of the syringe barrel 902. The dispensing opening at the distal end of the conduit 914 of the dispensing tip 912 is preferably covered by an end cap 916. The end cap 916 may cover the distal end of the dispensing tip 912 while the gas-sterilizable syringe 900 is being shipped and stored. In one embodiment, the end cap 916 can be removed from the distal end of the dispensing tip 912 in order to dispense and / or extrude a fluid material from the distal end of the syringe barrel 902.

[0247] In one embodiment, the syringe plunger 904 preferably includes a piston 918 (e.g., a plunger head) which can be disposed inside the fluid chamber 905 of the syringe barrel 902. The piston 918 preferably has an outer circumference that engages with the inner surface of the syringe barrel 902 to form a liquid-tight seal between the piston and the inner surface of the syringe barrel. In one embodiment, the piston 918 may be made from a variety of conventional materials, including rubber and / or polymers. The plunger 904 preferably includes a plunger stem 920 having a distal end fixed to the proximal side of the piston 918. In one embodiment, the plunger 904 preferably includes a thumb tab 922 fixed to the proximal end of the plunger stem 920. The thumb tab 922 may be pushed distally, indicated by DIR1, to force the piston 918 to slide distally toward the distal end wall 910 of the syringe barrel 902 within the fluid chamber 905. In one embodiment, with the end cap 916 removed, when the thumb tab 922 is pushed down distally in the DIR1 direction, the fluid material pre-loaded in the fluid chamber 905 of the syringe barrel 902 can be forced downstream and flow into the conduit 914 of the dispensing tip 912 so as to be squeezed out from the dispensing opening at the distal end of the dispensing tip 912.

[0248] In one embodiment, the syringe barrel 902 has an outer wall 924, and the gas-sterilizable syringe 900 may include one or more apertures 926 formed in the outer wall 924 of the syringe barrel 902 (e.g., perforated, laser-perforated, mechanically perforated).

[0249] In one embodiment, the gas-sterilizable syringe 900 may include one or more apertures 930 extending through the piston 918 of the syringe plunger 904. In one embodiment, one or more of the apertures 930 extending through the piston 918 may be located within and / or aligned with the plunger stem 920 of the plunger 904, which extends between the thumb tab 922 and the piston 918. The plunger 904 may be a vented plunger.

[0250] In one embodiment, the gas-sterilizable syringe 900 may include one or more apertures 932 formed on the distal end wall 910 of the syringe barrel 902.

[0251] In one embodiment, a gas-sterilizable syringe 900 may include one or more apertures 934 formed in the wall of an end cap 916, the wall of which can cover and secure a dispensing opening located at the distal end of a dispensing tip 912.

[0252] In one embodiment, the gas-sterilizable syringe 900 may include one or more apertures 936 extending through the outer wall of the dispensing tip 912.

[0253] In one embodiment, each of the apertures 926, 930, 932, 934, and 936 formed within the gas-sterilizable syringe 900 preferably has a diameter of about 1 to 5 mm.

[0254] In one embodiment, the apertures 926, 930, 932, 934, and 936 of a gas-sterilizable syringe 900 are preferably filled with a gas-permeable barrier 945 (i.e., a gas-permeable plug, a gas-permeable seal), the gas-permeable barrier 945 allowing sterilization gas to pass through the aperture to sterilize the gas-sterilizable syringe 900, while preventing a viscous fluid material disposed in the fluid chamber 905 of the syringe barrel 902 from passing through (e.g., leaking out) the apertures 926, 930, 932, 934, and 936 filled with the gas-permeable barrier 945.

[0255] In one embodiment, the formulation used to form a gas permeable barrier is preferably porous and curable, and can reliably block and / or seal the aperture without affecting the stability of the fluid material (e.g., silicone-based topical skin adhesive) stored in the enclosure (e.g., syringe).

[0256] In one embodiment, one or more of the apertures may have an asymmetric shape and / or cross-section, and the formulation used to form the gas permeable barrier is introduced into the aperture in an uncured state so that it can conform to the shape of the aperture before curing. After complete curing, the gas permeable barrier preferably conforms to the shape of the aperture to seal the opening, allowing sterile gases to pass through the aperture while preventing fluid materials from passing through the gas permeable barrier. In one embodiment, the material used to form the gas permeable barrier (e.g., silicone rubber) is preferably bonded to the material used to form the syringe.

[0257] Referring to FIG. 11A, in one embodiment, a gas-sterilizable syringe 1000 preferably includes a syringe barrel 1002 having an outer wall 1024 surrounding a fluid chamber 1005. In one embodiment, a plurality of apertures 1026 may be formed in the outer wall 1024 of the syringe barrel 1002. The apertures 1026 may have different shapes, configurations, and / or diameters. The apertures may have an asymmetric and / or non-uniform shape. The apertures 1026 can have a diameter of about 1 to 5 mm.

[0258] Referring to FIG. 11B, in one embodiment, each aperture 1026 formed in the outer wall 1024 of the syringe barrel 1002 allows a sterilizing gas to pass through the aperture 1026 to reach a viscous fluid material (not shown) disposed within the fluid chamber 1005, while preventing the viscous fluid material from leaking and / or escaping through the blocked aperture 1026, and may be filled with a gas-permeable barrier 1045 (e.g., a plug). In one embodiment, the porous material that fills the aperture 1026 to form the gas-permeable barrier 1045 may first fill the aperture when in an uncured, flowable state and then be cured to form the gas-permeable barrier. In the initial uncured state, the material used to form the gas-permeable barrier 1045 preferably conforms to the specific shape of the aperture 1026 associated with the gas-permeable barrier 1045. After being disposed within each of the apertures 1026 formed in the outer wall 1024 of the syringe barrel 1002 of the gas-sterilizable syringe 1000, the gas-permeable barrier material may be cured to form a structurally stable gas-permeable barrier 1045 (e.g., a plug) that fills each of the apertures 1026 formed in the outer wall 1024 of the syringe barrel 1002. In one embodiment, the gas-permeable barrier 1045 may be made of a porous silicone rubber that binds to one or more walls of the syringe and / or the syringe barrel 1002.

[0259] In one embodiment, the holes 926, 930, 932, 934, and 936 of the sterilizable syringe 900 shown in FIGS. 10A and 10B may have a shape, configuration, and / or diameter similar to the shape, configuration, and / or diameter of the hole 1026 shown in FIGS. 11A and 11B.

[0260] In one embodiment, a sacrificial sleeve may be used to form and / or mold a gas permeable barrier that fills holes formed in a sterilizable syringe. Referring to FIG. 12, in one embodiment, a gas sterilizable syringe 1100 preferably includes a syringe barrel 1102 having an outer wall 1124 surrounding a fluid chamber 1105, the fluid chamber 1105 being configured to receive a flowable material (e.g., a tissue adhesive). In one embodiment, one or more apertures 1126 are formed in the outer wall 1124 of the syringe barrel 1102 to provide communication with the fluid chamber 1105 of the syringe barrel 1102. In one embodiment, a sacrificial sleeve 1142 (e.g., a tubular structure) may be inserted into the syringe barrel 1102 before filling the apertures 1126 with a material that can be cured to form a gas permeable barrier 1145. The outer surface of the sacrificial sleeve 1142 may engage the inner surface 1140 of the outer wall 1124 of the syringe barrel 1102 or be positioned opposite and proximate to the inner surface 1140. With the sacrificial sleeve 1142 disposed inside the syringe barrel 1102 to cover the apertures 1126, a flowable curable porous material (e.g., silicone) may be disposed within the apertures 1126 to form a gas permeable barrier 1145 that fills the apertures 1126. The uncured material filling the holes 1126 preferably conforms to the shape of the holes and the outer surface of the sacrificial sleeve 1142 that contacts the uncured material. After the material disposed within the apertures 1126 has been cured, the sacrificial sleeve 1142 may be removed from inside the outer wall 1124 of the syringe barrel 1102 to provide a smooth interface between the gas permeable barrier 1145 and the inner surface 1140 of the outer wall 1124 of the syringe barrel 1102. In one embodiment, the sacrificial sleeve 1142 may be made of silicone rubber.

[0261] Referring to Figure 13, in one embodiment, the gas-sterilizable syringe 1200 preferably includes an enclosure 1202 (double-barrel syringe) having a proximal end 1204 and a distal end 1206. The enclosure 1202 preferably includes a first syringe barrel 1208 configured to receive a first portion of the fluid material and a second syringe barrel 1210 configured to receive a second portion of the fluid material.

[0262] In one embodiment, the enclosure 1202 preferably includes a first dispensing opening 1212 that fluidly communicates with the distal end of a first syringe barrel 1208, and a second dispensing opening 1214 that fluidly communicates with the distal end of a second syringe barrel 1210. In one embodiment, the first and second portions of the fluid material are extruded through the respective first and second dispensing openings 1212 and 1214, and then mixed together (e.g., using a static mixer) to form a biocompatible material used in surgical procedures, such as a silicone-based topical skin adhesive.

[0263] In one embodiment, the gas-sterilizable syringe 1200 preferably includes a double-barrel plunger 1216, which includes a first plunger 1218 configured to be inserted into the open end of a first syringe barrel 1208 and a second plunger 1220 configured to be inserted into the open end of a second syringe barrel 1210. In one embodiment, the gas-sterilizable syringe 1200 preferably includes a thumb tab 1222 that interconnects the proximal ends of the first plunger and the second plungers 1218, 1220. The thumb tab 1222 may be engaged to simultaneously push the first plunger and the second plungers 1218, 1220 distally DIR1 toward the distal end 1206 of the enclosure 1202, so that the first and second portions of the fluid material are then extruded from the respective dispensing openings 1212, 1214.

[0264] In one embodiment, the gas-sterilizable syringe 1200 preferably includes an end cap 1224 adapted to cover and secure dispensing openings 1212, 1214 located at the distal end 1206 of the enclosure 1202. In one embodiment, the distal end 1206 of the enclosure preferably includes end cap connecting flanges 1255A, 1255B configured to engage with radially extending projections 1265A, 1265B (Figure 15) provided on the outer surface of the hub of the end cap 1224 in order to secure the end cap 1224 to the distal end 1206 of the enclosure 1202 (e.g., a double-barrel syringe). The end cap 1224 preferably includes a first end cap opening 1226 and a second end cap opening 1228 formed internally. With the end cap 1224 fixed to the distal end 1206 of the enclosure 1202, the end cap openings 1226, 1228 are preferably adapted to allow sterilization gas to pass through the end cap 1224 and the first and second dispensing openings 1212, 1214 in order to sterilize the first and second portions of the fluid material disposed in the fluid chambers of the first and second syringe barrels 1208, 1210, respectively.

[0265] In one embodiment, the gas-sterilizable syringe 1200 preferably includes a gas-permeable barrier 1230 (e.g., a cured silicone plug) configured to be disposed within an end cap 1224 and positioned between the distal ends of the first and second dispensing openings 1212, 1214 and the inner surface of the end cap 1224. In one embodiment, the gas-permeable barrier may be made from silicone rubber having closed-cell porosity.

[0266] In certain embodiments, the gas permeable barrier 1230 may be made from one or more of the following materials, namely, silicone materials including room temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), and high viscosity rubber (HCR).

[0267] In one embodiment, the gas permeable barrier 1230 includes a closed-cell structure having voids and / or porosity. In one embodiment, the gas permeable barrier 1230 can be molded or die-cut. In one embodiment, the gas permeable barrier has no through holes (i.e., no open-cell pores) to seal the contents of a syringe barrel (e.g., a fluid material) during repeated vacuum cycles of a gas sterilization process (e.g., an ethylene oxide gas sterilization process).

[0268] In one embodiment, the gas permeable barrier 1230 disposed within the end cap 1224 may be made from various silicone rubber materials having a porosity range of 1% to 90% of the total volume, more preferably 5% to 80% of the total volume, and mainly having closed-cell porosity.

[0269] In one embodiment, the gas permeable barrier 1230 disposed within the end cap 1224 is made from a material that is compatible with the contents of a gas-sterilizable syringe and does not react chemically. Examples of preferred materials for the gas permeable barrier include, but are not limited to, silicone-polyethylene, silicone-acrylic, or silicone-polyurethane copolymers, which can be formed into the shape of the gas permeable barrier disclosed herein.

[0270] In one embodiment, the gas permeable barrier 1230 may be made from a porous silicone material having a Shore A hardness grade of 5 to 70.

[0271] In one embodiment, the porosity of the silicone polymer used to form the gas-permeable barrier 1230 can be generated during curing using an in-situ gas generation method.

[0272] In one embodiment, the gas-permeable barrier 1230 may be made using a commercially available silicone RTV foam, thereby the formulation may be modified to adjust the porosity level to optimize the results when used with a gas-sterilizable syringe.

[0273] In one embodiment, the gas permeable barrier 1230 can be molded or die-cut. In one embodiment, the gas permeable barrier can be die-cut from a larger porous silicone rubber sheet.

[0274] In one embodiment, the gas-permeable barrier may be made from other highly gas-permeable materials, such as rubber and / or polymer materials.

[0275] In one embodiment, after the gas permeable barrier 1230 is assembled with the end cap 1224, the end cap is preferably fixed to the distal end of the enclosure 1202. The hub of the end cap preferably forms an airtight seal with the distal end of the enclosure so that sterilization gas cannot pass between the lower end of the hub of the end cap and the distal end wall of the enclosure.

[0276] With the end cap 1224 fixed to the distal end 1206 of the enclosure 1202, the end cap openings 1226 and 1228 are preferably adapted to allow a sterilization gas to pass through the end cap 1224, the gas permeable barrier 1230, and the first and second dispensing openings 1212, 1214 in order to sterilize the first and second portions of the fluid material disposed in the fluid chambers of the first and second syringe barrels 1208, 1210, respectively.

[0277] Referring to Figure 14, in one embodiment, the gas permeable barrier 1230 is preferably porous to allow sterilization gas to pass through the gas permeable barrier in order to sterilize the first and second portions of the fluid material disposed within the enclosure 1202 (Figure 13) of the gas-sterilizable syringe 1200. In one embodiment, the gas permeable barrier 1230 is made of silicone rubber containing closed-cell pores. In one embodiment, the gas permeable barrier 1230 has no openings (e.g., micro-apertures) to prevent leakage of the fluid material disposed within the syringe during the sterilization process. The pores of the gas permeable barrier 1230 are not interconnected with each other and allow sterilization gas to pass through the gas permeable barrier while preventing portions of the fluid material from passing through the gas permeable barrier. Thus, the gas permeable barrier 1230 is designed to allow sterilization gas to pass through and / or prevent more viscous liquids from passing through the gas permeable barrier 1230 and / or flowing through the gas permeable barrier 1230.

[0278] Referring to Figure 15, in one embodiment, the end cap 1224 can cover and secure the dispensing openings 1212, 1214 (Figure 13) located at the distal ends of the respective first and second syringe barrels 1208, 1210. In one embodiment, the distal end 1206 of the enclosure 1202 (Figure 13) preferably includes end cap connecting flanges 1255A, 1255B, which are configured to engage with radially extending projections 12656A, 1265B (Figure 15) provided on the outer surface of the hub of the end cap 1224 in order to secure the end cap 1224 to the distal end 1206 of the enclosure 1202 (e.g., a double-barrel syringe). The lower end of the hub of the end cap 1224 preferably forms an airtight seal with the distal end of the enclosure 1202.

[0279] In one embodiment, the gas permeability barrier 1230 (FIG. 14) is disposed within the end cap 1224 and is aligned with a first end cap opening and a second end cap opening 1226, 1228 formed in the end cap 1224. The end cap 1224 preferably includes a first end cap opening 1226 and a second end cap opening 1228 that allow a sterilizing gas to pass through the end cap 1224 and the gas permeability barrier 1230 in order to sterilize portions of the flowable material disposed within the fluid chambers of the respective syringe barrels 1208, 1210.

[0280] In one embodiment, the sterilizing gas preferably passes through the first end cap opening and the second end cap opening 1226, 1228 and the gas permeability barrier 1230 in order to enter the respective fluid chambers of the first syringe barrel and the second syringe barrel 1208, 1210.

[0281] In one embodiment, the only inlet path for the sterilizing gas into the fluid chamber of the enclosure passes through the first end cap opening and the second end cap opening 1228 formed within the end cap 1224.

[0282] In one embodiment, an end cap for a gas-sterilizable syringe may have a single end cap opening.

[0283] In one embodiment, the end cap 1224 for a gas-sterilizable syringe may have three or more end cap openings.

[0284] In one embodiment, after the gas-sterilizable syringe 1200 has been sterilized, the end cap 1224 preferably remains in place (i.e., fixed to the distal end of the enclosure 1202) while the syringe is being shipped and stored. During surgical procedures, the end cap 1224 may be detached from the distal end 1206 of the enclosure and replaced by a mixing and dispensing tip or dispensing tip (not shown) that can be fixed to the distal end of the enclosure for mixing and / or extruding fluid materials disposed in the first and second syringe barrels 1208, 1210.

[0285] Experiment 1. Gas-sterilizable syringes having a structure similar to those shown in Figures 13-15, each containing a two-part silicone adhesive formulation, were sterilized using ethylene oxide (EO) gas. A biologic indicator (BI) was placed in the fluid chamber of each syringe barrel of the gas-sterilizable syringe to test the function of the gas-permeable barrier (e.g., gas-permeable plug) and / or gas-permeable plunger seal. The biologic indicators in all tested devices showed negative results, indicating that the ethylene oxide sterilization gas was able to enter the syringe and effectively sterilize each of the two parts of the silicone adhesive formulation contained within the syringe. The EO exposure time was 785 cycles (approximately 5 hours), after which a vacuum pressure of less than 50 mmHg was applied to remove residual EO gas from the sterilization chamber. The BI showed that all bacteria were neutralized by the EO cycle, demonstrating that the syringe was EO-permeable. Furthermore, the residual EO content in the sterilized syringes was tested. The test result was 3.59 μg / cm³. 2 The residual EO content was shown, which is 10 μg / cm³. 2 It is far below the required limit.

[0286] Referring to Figure 16A, in one embodiment, the gas-sterilizable syringe 1200 preferably includes an enclosure 1202 (e.g., a double-barrel syringe) having a first syringe barrel 1208 and a second syringe barrel 1210. An end cap 1224 is preferably fixed to the distal end 1206 of the enclosure 1202 to cover the first and second dispensing openings 1212, 1214 (Figure 13) located at the distal ends of the respective first and second syringe barrels 1208, 1210.

[0287] In one embodiment, the distal ends of the first and second plungers 1218, 1220 of the double-barrel plunger 1216 are inserted into openings located at the proximal ends of the first and second syringe barrels 1208, 1210, respectively. The distal end of the first plunger 1218 may include a first plunger seal 1219 configured to form a liquid-tight seal with the inner surface of the first syringe barrel 1208, and the distal end of the second plunger 1220 may include a second plunger seal 1221 configured to form a liquid-tight seal with the inner surface of the second syringe barrel 1210. In one embodiment, when the double-barrel plunger 1216 is assembled with the double-barrel syringe 1202, a sterilization gas can enter the first fluid chamber of the first syringe barrel by passing between the outer circumference of the first plunger seal 1219 and the inner surface of the outer wall of the first syringe barrel 1208 to sterilize the first portion of the fluid composition disposed in the first fluid chamber of the first syringe barrel. In one embodiment, a similar structure is provided for sterilizing the second portion of the fluid composition disposed in the second fluid chamber of the second syringe barrel 1210. In one embodiment, the sterilization gas can enter the second fluid chamber of the second syringe barrel by passing between the outer circumference of the second plunger seal 1221 and the inner surface of the outer wall of the second syringe barrel 1210 to sterilize the second portion of the fluid composition disposed in the second fluid chamber of the second syringe barrel 1210.

[0288] Referring to Figure 16B, in one embodiment, the first syringe barrel 1208 is preferably filled with a first portion of the fluid material, and the second syringe barrel 1210 is preferably filled with a second portion of the fluid material. The distal ends of the first and second plungers 1218, 1220 are preferably inserted into the openings at the proximal end 1204 of the enclosure 1202. The end caps 1224 are preferably fixed to the distal end 1206 of the enclosure 1202 to cover the dispensing openings 1212, 1214 (Figure 13) located at the distal ends of the respective first and second syringe barrels 1208, 1210.

[0289] The syringe and its contents are preferably sterilized by passing a sterile gas through the end cap opening of the end cap 1224. After the syringe 1200 is sterilized, the end cap 1224 preferably remains in place while the device is shipped and stored. During a surgical procedure, with the syringe located in a sterile environment, the end cap 1224 may be removed and replaced with a mixing and dispensing tip or dispensing tip, which is fixed to the distal end 1206 of the enclosure for mixing and / or dispensing the first and second portions of the fluid material contained in the respective first and second syringe barrels 1208, 1210.

[0290] Referring to Figure 17, in one embodiment, the gas-sterilizable syringe 1300 preferably includes an enclosure 1302 having a proximal end 1304 and a distal end 1306. The enclosure 1302 preferably includes a first syringe barrel 1308 having a first fluid compartment configured to receive a first portion of the fluid material, and a second syringe barrel 1310 having a second fluid compartment configured to receive a second portion of the fluid material.

[0291] In one embodiment, the enclosure 1302 preferably includes a first dispensing opening 1312 that is in fluid communication with a first fluid compartment of a first syringe barrel 1308, and a second dispensing opening 1314 that is in fluid communication with a second fluid compartment of a second syringe barrel 1310.

[0292] In one embodiment, the gas-sterilizable syringe 1300 preferably includes an end cap 1324 having a first end cap opening 1326 and a second end cap opening 1328. In one embodiment, the first end cap 1326 is preferably disposed within the end cap 1324 and adapted to receive a gas-permeable barrier 1330 (e.g., a gas-permeable plug) aligned with the first and second end cap openings 1326, 1328. In one embodiment, the end cap 1326 including the gas-permeable barrier 1330 is adapted to be fixed to the distal end 1306 of the enclosure 1302 to cover the dispensing openings 1312, 1314 at the distal ends of the respective first and second syringe barrels 1308, 1310. In one embodiment, the combination of the end cap 1324 and the gas permeable barrier 1330 allows a sterilization gas to pass through the end cap 1324 and the gas permeable barrier 1330 in order to sterilize the first and second portions of the fluid material disposed in the first and second syringe barrels 1308 and 1310, respectively.

[0293] In one embodiment, the gas-sterilizable syringe 1300 preferably includes a double-barrel plunger 1316, which includes a first plunger 1318 adapted to be disposed within a first syringe barrel 1308 and a second plunger 1320 adapted to be disposed within a second syringe barrel 1310. In one embodiment, the double-barrel plunger 1316 preferably includes thumb tabs 1322 fixed to the proximal ends of each of the first and second plungers 1318, 1320, thereby allowing the double-barrel plunger 1316 to be simultaneously pushed down toward the distal end 1306 of the enclosure 1302.

[0294] In one embodiment, the first gas-permeable plunger seal 1362 is preferably fixable to the distal end of the first plunger 1318, and the second gas-permeable plunger seal 1364 is preferably fixable to the distal end of the second plunger 1320. The first and second gas-permeable plunger seals 1362 and 1364 are preferably configured to allow sterilization gas to pass through the first and second gas-permeable plunger seals 1362 and 1364 to sterilize portions of fluid material disposed within the respective first and second syringe barrels 1308 and 1310. In one embodiment, the first and second gas-permeable plunger seals may be made from silicone rubber containing closed-cell pores. In one embodiment, no openings (e.g., micro-apertures) are present in the gas-permeable plunger seal to prevent leakage of the contents (e.g., fluid material) contained within the first and second syringe barrels during the sterilization process.

[0295] In one embodiment, the double barrel plunger 1316 may include vents and / or conduits that allow a sterilization gas to pass through to sterilize the first and second fluid compartments of the first and second syringe barrels 1308, 1310. The vents and / or conduits may be in fluid communication with the first and second gas-permeable plunger seals 1362, 1364.

[0296] In one embodiment, the end cap 1324 and the gas permeable barrier 1330 are fixed to cover the distal end 1306 of the enclosure 1302 to cover the openings of the first and second dispensing openings 1312, 1314. With the end cap 1324 and the gas permeable barrier 1330 fixed to the distal end of the enclosure 1302, sterilization gas can pass through the first and second end cap openings 1326, 1328, the gas permeable barrier 1330, and the dispensing openings 1312, 1314 to sterilize the first and second portions of fluid material disposed in the fluid chambers of the first and second syringe barrels 1308, 1310, respectively.

[0297] With the first plunger and the second plungers 1318, 1320 positioned in the first syringe barrel and the second syringe barrel 1308, 1310 respectively, sterilization gas can pass through the plungers and / or the first gas-permeable plunger seal and the second gas-permeable plunger seal 1362, 1364 to sterilize the portions of fluid material positioned in the first syringe barrel and the second syringe barrel 1308, 1310 respectively.

[0298] In one embodiment, the gas-sterilizable syringe preferably includes a mixing and dispensing tip 1350 which can be fixed to the distal end 1306 of the enclosure 1302. In one embodiment, the mixing and dispensing tip 1350 is preferably configured to mix a first portion and a second portion of a fluid composition together and to extrude the fluid composition from the distal end of the gas-sterilizable syringe 1300.

[0299] In one embodiment, the mixing and dispensing tip 1350 preferably has a mixing and dispensing tube 1352 having a proximal end 1354 and a distal end 1356. Preferably, a static mixer 1358 is disposed in the mixing and dispensing tube 1352 to mix together the first and second portions of the fluid material disposed in the respective first and second syringe barrels 1308, 1310.

[0300] In one embodiment, the mixing and dispensing tip 1350 preferably includes a connector 1360, which is adapted to connect the mixing and dispensing tip 1350 to the distal end 1306 of the enclosure 1302 of a gas-sterilizable syringe 1300. In one embodiment, the mixing and dispensing tip 1350 preferably includes one or more radially extending projections 1361 extending from the outer surface of the connector 1360. In one embodiment, the one or more radially extending projections 1361 are preferably configured to engage with fixing flanges 1385A, 1385B located at the distal end of the enclosure 1302 in order to secure the mixing and dispensing tip 1350 to the distal end of the enclosure 1302.

[0301] In one embodiment, during a surgical procedure, an end cap 1324 including a gas-permeable barrier 1330 may be detached from the distal end 1306 of the enclosure 1302 and replaced by a mixing and dispensing tip 1350. A connector 1360 located at the proximal end of the mixing and dispensing tip 1350 may cover and secure the exposed first and second dispensing openings 1312, 1314 located at the distal end 1306 of the enclosure 1302. One or more radially extending projections 1361 at the proximal end of the connector 1360 preferably engage with a fixing flange 1385 at the distal end of the enclosure 1302 to secure the mixing and dispensing tip to the distal end of the enclosure. The thumb tabs 1322 fixed to the proximal ends of the first and second plungers 1318 and 1320 are pushed downward toward the distal end 1306 of the enclosure 1302 in the distal direction DIR1, thereby forcing the first and second portions of the fluid material to flow from the first and second dispensing openings 1312 and 1314 into the mixing and dispensing tube 1352 of the mixing and dispensing tip 1350. As the first and second portions of the fluid material flow distally through the mixing and dispensing tube 1352 in the distal direction DIR1, the two portions of the fluid material are mixed together via a static mixer 1358 located within the mixing and dispensing tube 1352.

[0302] Referring to Figures 18A-18B, Figure 19, and Figure 20, in one embodiment, the gas-sterilizable syringe 1400 preferably includes an enclosure 1402 having a proximal end 1404 and a distal end 1406. In one embodiment, the enclosure 1402 is preferably a double-barrel syringe including a first syringe barrel 1408 having a first fluid compartment 1405A and a second syringe barrel 1410 having a second fluid compartment 1405B.

[0303] In one embodiment, the gas-sterilizable syringe 1400 preferably includes a double-barrel plunger 1416, which includes a first plunger 1418 adapted to be inserted into the proximal end of a first syringe barrel 1408 and a second plunger 1420 adapted to be inserted into the proximal end of a second syringe barrel 1410.

[0304] In one embodiment, the first plunger 1418 preferably includes a first plunger head 1419 located at the distal end of the first plunger 1418, and the second plunger 1420 preferably includes a second plunger head 1421 located at the distal end of the second plunger 1420. In one embodiment, the outer circumferences of the first plunger head and the second plunger heads 1419, 1421 preferably form a liquid-tight seal with the inner surfaces of the first syringe barrel and the second syringe barrels 1408, 1410, respectively.

[0305] In one embodiment, the double barrel plunger 1416 preferably includes a thumb tab 1422 that interconnects the proximal ends of the first plunger and the second plungers 1418, 1420. In one embodiment, the thumb tab 1422 may be used to push the double barrel plunger 1416 distally in DIR1 (Figures 18A and 18B) to extrude the first and second portions of the fluid material from the distal ends of the respective first and second syringe barrels 1408, 1410.

[0306] In one embodiment, the gas-sterilizable syringe 1400 preferably includes an end cap 1424 fixed to the distal end 1406 of the enclosure 1402. A gas permeable barrier 1430 (Figures 19 and 20) may be provided within the end cap 1424 to allow sterilization gas to pass through the end cap and enter the first and second fluid compartments 1405A and 1405B of the first and second syringe barrels 1408 and 1410, respectively, in order to sterilize the first and second portions of the fluid material disposed within the enclosure 1402, while preventing the fluid material from passing through the gas permeable barrier 1430. In one embodiment, the end cap 1424 preferably includes one or more end cap openings 1426 (Figure 18A) configured to allow a sterilization gas to pass through the end cap 1424 and the gas permeable barrier 1430 (Figures 19 and 20) in order to sterilize the first and second portions of the fluid material disposed in the first and second fluid chambers 1405A and 1405B of the first and second syringe barrels 1408 and 1410, respectively.

[0307] Referring to Figures 19 and 20, in one embodiment, the enclosure 1402 preferably includes a first dispensing opening 1412 that is in fluid communication with a first fluid compartment 1405A of a first syringe barrel 1408, and a second dispensing opening 1414 that is in fluid communication with a second fluid compartment 1405B of a second syringe barrel 1410.

[0308] In one embodiment, the first syringe barrel 1408 preferably has an outer wall 1425 having one or more ventilation openings 140 formed inside. The first syringe barrel 1408 preferably includes a first one-way plunger stopper 1442 formed on the inner surface of the outer wall 1425 located between one or more ventilation openings 1440 and the proximal end 1404 of the enclosure 1402. In one embodiment, after the first plunger head 1419 moves distally beyond the first one-way plunger stopper 1442, the first one-way plunger stopper 1442 engages with the first plunger to make it easier to move the first plunger 1418 distally in DIR1 and more difficult to move the first plunger 1418 proximal in DIR2.

[0309] In one embodiment, the first one-way plunger stopper 1442 is designed within the inner diameter of the first syringe barrel 1408 such that when the plunger is inserted into the filled syringe, the plunger can easily overcome the tapered introduction portion to the first one-way plunger stopper 1442, but after passing through the first one-way plunger stopper 1442, it rides up onto the first one-way plunger stopper 1442 and cannot retract from this resting position unless excessive force is applied. In one embodiment, the one-way plunger stopper 1442 is designed to prevent movement of the first plunger during pressure changes and vacuum cycles that occur during sterilization.

[0310] In one embodiment, the first syringe barrel 1424 preferably includes an elongated ridge 1444 formed on the inner surface of the outer wall 1424 extending along the length of the first syringe barrel 1408. The elongated ridge 1444 preferably terminates adjacent to a one-way plunger stopper 1442 of the first syringe barrel 1408. The elongated ridge 1444 preferably guides the sliding motion of the first plunger 1418 relative to the first syringe barrel 1408.

[0311] In one embodiment, the second syringe barrel 1410 preferably includes an outer wall 1427 having one or more ventilation holes 1446 formed inside. The second syringe barrel 1410 preferably includes a second one-way plunger stopper 1448 located between one or more ventilation holes 1446 of the second syringe barrel and the proximal end 1404 of the enclosure 1402. In one embodiment, after the second plunger head 1420 has moved distally beyond the second one-way plunger stopper 1448, the second one-way plunger stopper 1448 engages with the second plunger 1420 to make it easier to move the second plunger 1420 distally DIR1, while making it more difficult to retract the second plunger 1420 proximal DIR2. The second syringe barrel 1410 preferably includes an elongated rib 1450 that extends along the length of the second syringe barrel 1410 and terminates adjacent to the second unidirectional plunger stopper 1448. The elongated rib 1450 preferably guides the sliding motion of the second plunger 1420 relative to the second syringe barrel 1410.

[0312] In one embodiment, the second one-way plunger stopper 1448 is designed within the inner diameter of the second syringe barrel 1410 such that when the plunger is inserted into the filled syringe, the plunger easily overcomes the tapered introduction portion to the second one-way plunger stopper 1448, but after passing through the second one-way plunger stopper 1448, it rides up onto the second one-way plunger stopper 1448 and cannot retract from this resting position unless excessive force is applied. In one embodiment, the second one-way plunger stopper 1448 is designed to prevent movement of the second plunger during pressure changes and vacuum cycles that occur during sterilization.

[0313] In certain embodiments, it may be advantageous to use syringes having a single external dimensional footprint for a product line offering multiple different filling volumes. A shared footprint may be desired to be simplified to a single shared rigid blister packaging for syringes with different filling volumes. The exact locations of the one-way plunger stoppers 1442, 1448 within the syringe barrel may be modified, adjusted, and / or customized so that the one-way plunger stoppers are positioned inside the syringe barrel at various desired filling volume levels, enabling a single syringe footprint with different filling volumes. For syringes designed to have larger filling volumes, the one-way plunger stoppers are positioned further away from the distal end of the syringe barrel, and for syringes designed to have smaller filling volumes, the one-way plunger stoppers are positioned closer to the distal end of the syringe barrel.

[0314] In one embodiment, the gas-sterilizable syringe 1400 is preferably located at the proximal end 1404 of the enclosure 1402 and includes a circumferential flange 1452 extending around the proximal ends of the first and second syringe barrels 1408, 1410, respectively. In one embodiment, the circumferential flange 1452 preferably interconnects the proximal ends of the first and second syringe barrels 1408, 1410. The user may engage the circumferential flange with their fingers to extrude fluid material from the distal end of the gas-sterilizable syringe.

[0315] In one embodiment, the gas-sterilizable syringe 1400 preferably includes end cap connecting flanges 1454A, 1454B located at the distal end 1406 of the enclosure 1402, which are configured to engage with radially extending projections 1456A, 1456B provided on the outer surface of the end cap 1424 in order to releasably secure the end cap 1424 to the distal end 1406 of the enclosure 1402. The end cap, when preferably secured to the distal end of the enclosure, forms an airtight seal with the distal end wall of the enclosure.

[0316] Referring to Figures 21A-21B and 22A-22B, in one embodiment, the dual barrel plunger 1416 preferably includes a first plunger 1418 and a second plunger 1420. A thumb tab 1422 interconnects the proximal ends of the first and second plungers 1418 and 1420, respectively.

[0317] In one embodiment, the first plunger 1418 preferably includes a first plunger shaft 1458 having a proximal end 1460 and a distal end 1462. The first plunger 1418 preferably includes an elongated guide rail 1464 extending along the length of the first plunger shaft across the outer surface of the first plunger shaft 1458. In one embodiment, the elongated guide rail 1464 preferably terminates at the distal end 1462 of the first plunger shaft 1458. In one embodiment, the distal end 1462 of the first plunger shaft 1458 preferably includes one or more radially extending projections 1466 adapted to engage with the first one-way plunger retainer 1442 of the first syringe barrel 1408 (Figure 19) to prevent the first plunger from retracting after the radially extending projections 1466 have moved distally beyond the first one-way plunger retainer 1442.

[0318] In one embodiment, the first plunger head 1419 is spaced apart from the distal end 1462 of the first plunger shaft 1458 and defines a first plunger cavity 1468 located between the distal end of the first plunger shaft and the first plunger head 1419.

[0319] In one embodiment, the second plunger 1420 preferably includes a second plunger shaft 1470 having a proximal end 1472 and a distal end 1474. The second plunger 1420 preferably includes an elongated guide rail 1476 extending along the length of the second plunger shaft 1470 across its outer surface. The elongated guide rail 1476 preferably terminates at the distal end 1474 of the second plunger shaft 1470. In one embodiment, the distal end 1474 of the second plunger shaft 1470 preferably includes one or more radially extending projections 1478 adapted to engage with the second one-way plunger retainer 1448 of the second syringe barrel 1410 (Figure 19) to prevent the second plunger from retracting after the radially extending projections 1478 have moved distally beyond the second one-way plunger retainer 1448.

[0320] In one embodiment, the second plunger head 1421 is spaced apart from the distal end 1474 of the second plunger shaft 1470 and defines a second plunger cavity 1480 located between the distal end of the second plunger shaft 1470 and the second plunger head 1421.

[0321] Referring to Figure 23, in one embodiment, the dual-barrel syringe 1402 is shown in Figures 21A-21B and 22A-22B and is configured to receive the dual-barrel plunger 1416 described above. In one embodiment, the first syringe barrel 1408 is configured to receive the first plunger 1418 (Figures 21A and 21B), and the second syringe barrel 1410 is configured to receive the second plunger 1420 (Figures 21A and 21B).

[0322] Referring to Figures 23 and 24, in one embodiment, the first syringe barrel 1408 preferably includes an outer wall 1425 extending along the length of the first syringe barrel. The first syringe barrel 1408 preferably includes one or more vents 1440 passing through the outer wall 1425. The vents 1440 allow ambient air present inside the first syringe barrel 1408 to be pushed out of the first syringe barrel. The vents 1440 may also provide an auxiliary path for sterilization gas into the fluid chamber 1405A of the first syringe barrel. The first one-way plunger stopper 1442 is preferably formed on the inner surface of the outer wall 1425 of the first syringe barrel 1408. The first one-way plunger stopper 142 may be a recess or projection. One or more elongated guide slots 1444 (e.g., spirals) are formed on the inner surface of the outer wall 1425 and extend along the length of the first syringe barrel 1408. In one embodiment, one or more elongated guide slots 1444 are adapted to receive one or more guide rails 1464 that extend along the length of the first plunger 1418 (Figures 21A and 21B).

[0323] Referring to Figure 23, in one embodiment, the second syringe barrel 1410 preferably includes an outer wall 1427 extending along the length of the second syringe barrel. The second syringe barrel 1410 preferably includes one or more vents 1446 passing through the outer wall 1427. The vents 1446 allow ambient air present inside the second syringe barrel 1410 to be pushed out of the second syringe barrel. The vents 1446 may also provide an auxiliary path for sterilization gas into the fluid chamber 1405B of the second syringe barrel 1410. A second one-way plunger stopper 1448 is preferably formed on the inner surface of the outer wall 1427 of the first syringe barrel 1410. One or more elongated guide slots 1450 (e.g., spirals) are formed on the inner surface of the outer wall and extend along the length of the second syringe barrel 1410. In one embodiment, one or more elongated guide slots 1450 are adapted to receive one or more guide rails 1476 that extend along the length of the second plunger 1420 of the double barrel plunger (Figures 21A and 21B).

[0324] Referring to Figure 25, in one embodiment, the first syringe barrel 1408 includes an outer wall 1425 extending along the length of the first syringe barrel. One or more elongated guide slots of the first syringe barrel may be evenly spaced from one another across the inner surface of the first syringe barrel 1408. In one embodiment, the one or more elongated guide slots preferably include four elongated guide slots 1444A to 1444D formed on the inner surface of the outer wall 1425 of the first syringe barrel 1408. In one embodiment, the four elongated guide slots 1444A to 1444D extend along their respective axes which are parallel to each other.

[0325] In one embodiment, the second syringe barrel 1410 includes an outer wall 1427 extending along the length of the first syringe barrel. One or more elongated guide slots of the second syringe barrel may be evenly spaced apart from one another across the inner surface of the second syringe barrel 1410. In one embodiment, the one or more elongated guide slots preferably include four elongated guide slots 1450A to 1450D formed on the inner surface of the outer wall 1427 of the second syringe barrel 1410. In one embodiment, the four elongated guide slots 1450A to 1450D extend along their respective axes which are parallel to each other.

[0326] Referring to Figure 26, in one embodiment, the first plunger 1418 includes a first plunger shaft 1458 extending along the length of the first plunger. In one embodiment, one or more elongated guide rails preferably include four elongated guide rails 1464A to 1464D formed on the outer surface of the first plunger shaft 1458 of the first plunger 1418. In one embodiment, the four elongated guide rails 1464A to 1464D are evenly spaced apart from each other across the outer surface of the first plunger shaft 1458 of the first plunger 1418. In one embodiment, the four elongated guide rails 1464A to 1464D extend along their respective axes which are parallel to each other.

[0327] In one embodiment, the second plunger 1420 includes a second plunger shaft 1470 that extends along the length of the second plunger. In one embodiment, one or more elongated guide rails preferably include four elongated guide rails 1476A to 1476D formed on the outer surface of the second plunger shaft 1470 of the second plunger 1420. In one embodiment, the four elongated guide rails 1476A to 1476D are evenly spaced apart from each other across the outer surface of the second plunger shaft 1470 of the second plunger 1420. In one embodiment, the four elongated guide rails 1476A to 1476D extend along their respective axes which are parallel to each other.

[0328] Referring to Figure 27, in one embodiment, when the dual-barrel syringe and dual-barrel plunger are assembled together, the first plunger 1418 is inserted into the first syringe barrel 1408, and the second plunger 1420 is inserted into the second syringe barrel 1410.

[0329] In one embodiment, the four elongated guide rails 1464A to 1464D (Figure 26) of the first plunger 1418 are seated in the four elongated guide slots 1444A to 1444D (Figure 25) of the first syringe barrel 1408 to guide the sliding motion of the first plunger toward the distal end 1406 of the enclosure 1402.

[0330] In one embodiment, the four elongated guide rails 1476A to 1476D (Figure 26) of the second plunger 1420 are seated in the four elongated guide slots 1450A to 1450D (Figure 25) of the second syringe barrel 1410 to guide the sliding motion of the second plunger toward the distal end 1406 of the enclosure 1402.

[0331] Referring to Figure 28A, in one embodiment, a dual barrel plunger 1416 (Figure 21A) is inserted into a double-barrel syringe 1402 such that the first plunger 1418 is located in the first syringe barrel 1408 and the second plunger 1420 is located in the second syringe barrel 1410. In one embodiment, the first plunger and the second plungers 1418, 1420 can be advanced distally in the direction DIR1 to the position shown in Figure 28A, such that the first plunger head 1419 is distal to one or more ventilation openings 1440 of the first syringe barrel 1408, the distal end 1462 of the first plunger shaft 1458 is proximal to one or more ventilation openings 1440 of the first syringe barrel 1408, and the first plunger cavity 1468 is aligned with one or more ventilation openings 1440 of the first syringe barrel 1408. A radial projection 1466 located at the distal end 1462 of the first plunger barrel shaft 1458 engages with the first unidirectional plunger stopper 1442 of the first syringe barrel to prevent the first plunger 1418 from retracting in the proximal direction DIR2.

[0332] Simultaneously, the second plunger head 1421 is distal to one or more vent openings 1446 of the second syringe barrel 1410, the distal end 1474 of the second plunger shaft 1470 is proximal to one or more vent openings 1446 of the second syringe barrel 1410, and the second plunger cavity 1480 is aligned with one or more vent openings 1446 of the second syringe barrel 1410. A radial projection 1478 located at the distal end 1474 of the second plunger shaft 1470 engages with a second unidirectional plunger retainer 1448 of the second syringe barrel 1410 to prevent the second plunger 1420 from retracting in the proximal direction DIR2.

[0333] Referring to Figure 28B, with the first plunger head 1419 distal to one or more ventilation openings 1440A, 1440B of the first syringe barrel 1408, the distal end 1462 of the first plunger shaft 1458 is proximal to the ventilation openings 1440A, 1440B extending through the outer wall 1425 of the first syringe barrel 1408. The first plunger cavity 1468, located between the first plunger head 1419 and the distal end 1462 of the first plunger shaft 1458, is aligned with the ventilation openings 1440A, 1440B extending through the outer wall 1425 of the first syringe barrel 1408.

[0334] In one embodiment, a first portion of a fluid composition is disposed within a first fluid compartment 1405A of a first syringe barrel 1408. A first plunger head 1419 has an outer circumference that forms a liquid-tight and / or fluid-sealed seal with the inner surface of the outer wall 1425 of the first syringe barrel 1408. Sterilization gas passes through vent openings 1440A, 1440B, flows between the outer circumference of the first plunger head 1419 and the inner surface of the outer wall 1425 of the first syringe barrel 1408, and can enter the first fluid chamber 1405A to sterilize the first portion of the fluid composition disposed within the first fluid chamber 1405 of the first syringe barrel. A similar structure is provided for sterilizing a fluid composition disposed within a second fluid chamber of a second syringe barrel.

[0335] Referring to Figures 29A to 29D, in one embodiment, the end cap 1424 is configured to be fixed to the distal end of the enclosure 1402 (Figures 18A and 18B). The end cap preferably includes a first end cap opening and a second end cap opening 1426A, 1426B, which allow sterilization gas to pass through the end cap to sterilize the gas-sterilizable syringe 1400 and the first and second portions of the fluid composition disposed in the first and second syringe barrels 1408, 1410 (Figures 18A and 18B).

[0336] In one embodiment, the end cap 1424 includes a central hub 1484 having radially extending projections 1456A and 1456B that extend outward from the central hub 1484. The end cap 1424 includes an end cap grip 1486 that protrudes from the distal end of the end cap, and the end cap grip 1486 may be used to secure the end cap to the distal end of the enclosure 1402 of a gas-sterilizable syringe (Figures 18a and 18B).

[0337] Referring to Figure 30, in one embodiment, the end cap 1424 includes a central hub 1484 having an open lower end and an upper end closed by an end wall 1485. The end cap openings 1426A, 1426B pass through the end wall 1485 of the end cap. The hub 1484 and the end wall 1485 of the end cap define an end cap chamber 1495 adapted to receive a gas permeable barrier 1430.

[0338] Referring to Figure 31, in one embodiment, the gas permeable barrier 1430 can be inserted into the end cap chamber 1495, so that the end cap openings 1426A and 1426B are preferably aligned with the gas permeable barrier 1430. In one embodiment, the gas permeable barrier 1430 is preferably positioned adjacent to the upper end of the central hub 1484 so that it is located near the bottom surface of the end cap end wall 1495. The lower end of the central hub 1484 preferably forms an airtight seal with the distal end wall of the enclosure or syringe so that the sterilization gas can flow into the gas-sterilizable syringe only through the first end cap opening and the second end cap openings 1426A and 1426B.

[0339] Referring to Figure 32, in one embodiment, an end cap 1424 having a gas-permeable barrier 1430 disposed inside can be fixed to the distal end 1406 of an enclosure 1402 of a gas-sterilizable syringe 1400. In one embodiment, the open lower end of the hub 1484 of the end cap 1424 is positioned over the free ends of the first and second dispensing openings 1412, 1414 of the enclosure 1402. An end cap grip 1486 can be used to rotate the end cap 1424 relative to the distal end 1406 of the enclosure 1402, thereby engaging the radially extending first and second projections 1566A, 1456B of the end cap with the end cap fixing flanges 1454A, 1454B of the enclosure to fix the end cap 1424 over the first and second dispensing openings 1412, 1414. The lower end of the hub of the end cap, when fixed to the enclosure, preferably forms an airtight seal with the distal end of the enclosure.

[0340] In one embodiment, with the end cap 1424 fixed to the distal end 1406 of the enclosure 1402, the gas permeable barrier 1430 is disposed between the end cap openings 1426A and 1426B (Figure 33) and the first and second fluid chambers 1405A and 1405B, respectively, and the first and second dispensing openings 1412 and 1414 that are in fluid communication with them. In one embodiment, a gas-sterilizable syringe 1400 may be exposed to a sterilization gas, which then passes through the end cap openings 1426A, 1425B, the gas-permeable barrier 1430, the first and second dispensing tips 1412, 1414, and enters the first and second fluid chambers 1405A, 1405B to sterilize the inside of the gas-sterilizable syringe 1400 and the portions of fluid material disposed within the first and second fluid chambers.

[0341] In one embodiment, the sterilization gas may also pass through the vent openings 1440, 1446 of the first and second syringe barrels 1408, 1410 to provide an auxiliary path for the sterilization gas to enter the first and second fluid chambers 1405A, 1405B of the syringe barrels 1408, 1410 of the gas-sterilizable syringe 1400.

[0342] In one embodiment, a gas-sterilizable syringe 1400 may be filled with a first portion and a second portion of a fluid material (e.g., a silicone-based topical skin adhesive). In one embodiment, the open proximal ends of the first syringe barrel and the second syringe barrels 1408, 1410 are filled with the fluid material, with an end cap 1424 and a gas-permeable barrier 1430 covering and securing the distal end 1406 of the enclosure 1402. In one embodiment, the first portion of the fluid material is disposed in the first fluid chamber 1405A of the first syringe barrel 1408, and the second portion of the fluid material is disposed in the second fluid chamber 1405B of the second syringe barrel 1410.

[0343] In one embodiment, a double-barrel plunger 1416 is assembled with a double-barrel syringe 1402 so that a first plunger 1418 is positioned in the first fluid chamber 1405A of the first syringe barrel 1408, and a second plunger 1420 is positioned in the second fluid chamber 1405B of the second syringe barrel 1410. The double-barrel plunger 1416 is then advanced distally in the direction DIR1 to expel any air present in the first and second syringe barrels 1408 and 1410 through vents 1440 and 1446 formed in the first and second syringe barrels.

[0344] In one embodiment, in the stationary position shown in Figure 32, the radial projection at the distal end of the plunger shaft preferably engages with unidirectional plunger stoppers 1442, 1448 (Figure 28A) to prevent the retraction of the first and second plungers. The plunger cavities 1468, 1480 are preferably aligned with their respective vent openings 1440, 1446, so that the vent openings preferably provide an auxiliary path for sterilization gas to enter the first and second fluid compartments 1405A, 1405B of the first and second syringe barrels 1408, 1410, respectively.

[0345] In one embodiment, the sterilization gas preferably enters the first fluid chamber 1405A of the first syringe barrel by passing through one or more vent openings 1440 of the first syringe barrel 1408, entering the first plunger cavity 1468, and entering between the outer circumference of the first plunger head 1419 and the inner surface of the outer wall 1425 of the first syringe barrel, thereby providing an auxiliary path for the sterilization gas to flow into the first fluid chamber 1405A.

[0346] In one embodiment, the sterilization gas preferably passes through one or more vent openings 1446 of the second syringe barrel 1410 to enter the second fluid chamber 1405B of the second syringe barrel, enters the second plunger cavity 1480, and enters between the outer circumference of the second plunger head 1421 and the inner surface of the outer wall 1427 of the second syringe barrel 1410, thereby providing an auxiliary path for the sterilization gas to flow into the second fluid chamber 1405B.

[0347] Referring to Figure 33, in one embodiment, the gas-sterilizable syringe 1500 preferably includes an enclosure 1502 having a first syringe barrel 1508 and a second syringe barrel 1510. The gas-sterilizable syringe 1500 preferably includes a double-barrel plunger 1516, which includes a first plunger 1518 disposed in the first syringe barrel 1508 and a second plunger 1520 disposed in the second syringe barrel 1510.

[0348] Referring to Figures 34A and 34B, in one embodiment, a gas-sterilizable syringe 1500 (Figure 33) preferably includes a multifunction connector 1582 that enables sterilization, mixing, and dispensing operations. In one embodiment, the multifunction connector preferably includes a first hub 1583 adapted to connect to the distal end of a first syringe barrel 1508 (Figure 33) and a second hub 1584 adapted to be fixed to the distal end of a second syringe barrel 1510 (Figure 33). The multifunction connector 1582 preferably includes a male threaded post 1585 extending distally from the first and second hubs 1583, 1584. In one embodiment, a flange 1586 extending distally bisects a threaded post 1585 in order to divide the threaded post 1584 into a first D-shaped opening 1587 and a second D-shaped opening 1588.

[0349] Referring to Figure 35, in one embodiment, the first D-shaped opening 1587 of the multifunction connector 1582 is adapted to receive a first gas permeable barrier 1530A (e.g., a first gas permeable plug), and the second D-shaped opening 1588 of the multifunction connector 1582 is adapted to receive a second gas permeable barrier 1530B (e.g., a second gas permeable plug). In one embodiment, the first gas permeable barrier 1530A has a D shape that matches the shape of the first D-shaped opening 1587 of the connector 1582, and the second gas permeable barrier 1530B has a D shape that matches the shape of the second D-shaped opening 1588 of the connector 1582.

[0350] Referring to Figures 35 and 36, in one embodiment, after the first and second gas permeable barriers 1530A and 1530B are inserted into the respective D-shaped openings 1587 and 1588 of the multifunction connector 1582, an end cap 1524 having a central opening 1526 is positioned over the gas permeable barriers and the distal ends of the threaded post 1585. A flange 1586 extending distally from the multifunction connector 1582 bisects the central opening 1526 of the end cap 1524. In one embodiment, the end cap 1524 has a female thread (not shown) adapted to mesh with the male thread of the threaded post 1585 in order to secure the end cap 1524 to the threaded post 1585.

[0351] Referring to Figures 33, 36, and 37, in one embodiment, the multifunctional connector 1582 may be assembled with the distal ends of the first syringe barrel and the second syringe barrels 1508 and 1510 of a gas-sterilizable syringe 1500. In one embodiment, the distal end of the first syringe barrel 1508 is preferably insertable into the first hub 1583 of the multifunctional connector 1582, and the distal end of the second syringe barrel 1510 is preferably insertable into the second hub 1584 of the multifunctional connector 1582.

[0352] Referring to Figure 37, in one embodiment, the multifunctional connector 1582 preferably includes a first hub 1583 configured to be fixed to the distal end of a first syringe barrel 1508 (Figure 33) and a second hub 1584 configured to be fixed to the distal end of a second syringe barrel 1510 (Figure 33). A distally extending flange 1586 of the connector 1582 bisects the threaded post 1585 to divide it into a first D-shaped opening 1587 located on one side of the distally extending flange 1586 and a second D-shaped opening 1588 located on the opposite side of the distally extending flange 1586. Gas permeable barriers 1530A and 1530B (Figure 35) are inserted into the respective D-shaped openings 1587 and 1588.

[0353] Referring to Figures 35, 36, 38, and 39, in one embodiment, the end cap 1524 can be unscrewed from its connection with the threaded post 1585 of the multifunction connector 1582. The first and second gas permeable barriers 1530A and 1530B can be removed from the respective D-shaped openings 1587 and 1588 of the threaded post 1585. After removing the end cap 1534 and the gas permeable barriers 1530A and 1530B, the mixing and dispensing tip 1550 can be screwed onto the threaded post 1585 of the multifunction connector 1582 to extrude fluid material from the syringe 1500.

[0354] Referring to Figure 38, in one embodiment, the mixing and dispensing tip 1550 preferably includes one or more radially extending projections 1561 extending from the outer surface of the connector 1560. The one or more radially extending projections 1561 are preferably adapted to engage with a fixed flange located at the distal end of the enclosure (e.g., syringe, dual-barrel syringe) in order to secure the mixing and dispensing tip 1550 to the distal end of the enclosure.

[0355] Referring to Figures 38 and 39, in one embodiment, the mixing and dispensing tip 1550 is preferably configured to mix a first portion and a second portion of the fluid composition together and to extrude the fluid composition from the distal end of a gas-sterilizable syringe 1500.

[0356] In one embodiment, the mixing and dispensing tip 1550 preferably has a mixing and dispensing tube 1552 having a proximal end 1554 and a distal end 1556. A static mixer 1558 is preferably disposed within the mixing and dispensing tube 1552 to mix together a first portion and a second portion of a fluid material disposed within the respective first and second syringe barrels 1508, 1510. The static mixer 1558 is configured to mix the first portion and the second portion of the fluid material together as the first portion flows along the length of the mixing and dispensing tube 1552.

[0357] In one embodiment, the mixing and dispensing tip 1550 preferably includes a connector 1560 having a female thread (not shown), the female thread being configured to engage with the male thread of a male-threaded post 1585 (Figure 35). In one embodiment, the gas-sterilizable syringe 1500 preferably includes a dual-barrel plunger 1516 having a first plunger 1518 and a second plunger 1520. The gas-sterilizable syringe 1500 preferably includes a thumb tab 1522, the thumb tab 1522 can be pushed distally DIR1 toward the distal end 1506 of the double-barrel syringe 1502 to force the contents in the first and second syringe barrels 1508, 1510 into the mixing and dispensing tip 1550.

[0358] Referring to Figure 39, in one embodiment, the fluid material can be dispensed and / or extruded from the mixing and dispensing tip 1550 by pushing down the thumb tab 1522 of the dual barrel plunger 1516 distally, represented as DIR1, in order to forcibly extrude two portions of the fluid material into the proximal end 1554 of the mixing and dispensing tube 1552. The static mixer 1558 is preferably configured to mix the first and second portions of the fluid material together as they flow along the length of the static mixer 1558 and the mixing and dispensing tube 1552. In one embodiment, during a surgical procedure, the fluid material is preferably extruded from the distal end 1556 of the mixing and dispensing tube 1552.

[0359] Referring to Figure 40, in one embodiment, the multifunctional connector 1582 preferably includes a threaded post 1585 (Figure 35) and a dividing wall 1586 that divides the threaded post 1585 into a first D-shaped opening 1587 and a second D-shaped opening 1588. The first and second hubs 1583, 1584 of the multifunctional connector 1582 define a cross-sectional area substantially similar to that of the first and second syringe barrels 1508, 1510 (Figure 33). The D-shaped openings 1587, 1588 preferably define a cross-sectional area that is 20% of the cross-sectional area defined by the first hub 1583 and the second hub 1584 of the multifunctional connector 1582.

[0360] Figure 41 shows a prior art connector 82 having dispensing openings 87, 88 that include only 5% of the cross-sectional area defined by the first hub 83 and the second hub 84 of the prior art connector 82.

[0361] The multifunctional connector 1582 shown in Figure 40 offers advantages over the prior art connector 82 shown in Figure 41. Firstly, the multifunctional connector has larger outlets (i.e., D-shaped openings 1587 and 1588) than the outlets (i.e., dispensing openings 87 and 88). The novel syringe design having D-shaped openings 1587 and 1588 and a gas-permeable stopper inserted into the D-shaped openings improves the sterilization of the gas-permeable syringe because the larger outlet of the syringe allows more sterile gas to enter the syringe. In addition, the larger size of the D-shaped openings 1587 and 1588 reduces the pressure required to extrude the fluid composition.

[0362] While the above description applies to embodiments of the present invention, other and further embodiments of the present invention can be devised without departing from the basic scope of the present invention, and the scope of the present invention is limited only by the appended claims. For example, in the present invention, any feature shown in any of the embodiments described herein or incorporated by reference herein can be incorporated together with any feature shown in any of the other embodiments described herein or incorporated by reference herein, and may still be included within the scope of the present invention.

[0363] [Implementation Method] (1) A syringe that can be sterilized by gas, An enclosure having a wall that defines a fluid chamber, A fluid material disposed within the fluid chamber of the enclosure, A plunger assembled together with the enclosure and movable toward the distal end of the enclosure for dispensing the fluid material from the enclosure, One or more apertures formed in at least one of the walls of the enclosure, A gas-sterilizable syringe comprising: a gas-permeable barrier covering at least one of the apertures formed in at least one of the walls of the enclosure, the gas-permeable barrier allowing a sterilizing gas to pass through at least one of the apertures covered by the gas-permeable barrier, while preventing the flowable material from passing through at least one of the apertures covered by the gas-permeable barrier. (2) The gas-sterilizable syringe according to Embodiment 1, wherein the gas-permeable barrier covering at least one of the apertures formed in at least one of the walls of the enclosure is permeable to the sterilization gas and impermeable to the fluid material disposed in the fluid chamber of the enclosure. (3) The gas-sterilizable syringe according to Embodiment 2, wherein the gas-permeable barrier has closed porosity configured to allow the sterilization gas to enter and exit during the sterilization procedure, and to prevent the fluid material from passing through the gas-permeable barrier. (4) The gas-sterilizable syringe according to Embodiment 1, wherein the one or more apertures formed in at least one of the walls of the enclosure comprises a plurality of apertures formed in at least one of the walls of the enclosure, and the gas-permeable barrier comprises a plurality of gas-permeable bodies filling each of the plurality of apertures formed in at least one of the walls of the enclosure. (5) The gas-sterilizable syringe according to Embodiment 4, wherein the plurality of gas-permeable bodies filling each of the plurality of apertures are coupled to at least one of the walls of the enclosure.

[0364] (6) The gas-sterilizable syringe according to Embodiment 1, wherein the gas-permeable barrier is made from a material selected from the group consisting of silicone, room-temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), high viscosity rubber (HCR), and synthetic flash-spun high-density polyethylene fibers. (7) The gas-sterilizable syringe according to Embodiment 1, wherein the sterilization gas comprises ethylene oxide, and the fluid material is selected from the group comprising liquids and topical skin adhesives, including silicone-based topical skin adhesives. (8) The enclosure is A syringe barrel surrounding the fluid chamber, The dispensing opening located at the distal end of the syringe barrel, The syringe barrel comprises a plunger that is movable toward the distal end of the syringe barrel for dispensing the fluid material through the dispensing opening located at the distal end of the syringe barrel, A gas-sterilizable syringe according to Embodiment 1, wherein the gas-permeable barrier covers the dispensing opening to allow the sterilization gas to pass through, while preventing the fluid material from passing through the dispensing opening. (9) An end cap fixed to the distal end of the syringe barrel and covering the dispensing opening, The end cap further comprises one or more end cap openings formed in the end cap to allow the sterilization gas to pass through the end cap, The gas permeable barrier is disposed inside the end cap and is located between the one or more end cap openings and the dispensing opening at the distal end of the syringe barrel. A gas-sterilizable syringe according to Embodiment 8, wherein the end cap has a central hub, and the central hub engages with the distal end wall of the syringe barrel to form an airtight seal between the central hub of the end cap and the distal end wall of the syringe barrel. (10) A syringe that can be sterilized by gas, A dual-barrel syringe comprising a first syringe barrel having a first fluid chamber and a first fluid dispensing opening, and a second syringe barrel having a second fluid chamber and a second fluid dispensing opening, A dual-barrel plunger comprising a first plunger disposed in the first fluid chamber of the first syringe barrel and a second plunger disposed in the second fluid chamber of the second syringe barrel, An end cap, releasably fixed to the distal end of the dual-barrel syringe to cover the first fluid dispensing opening and the second fluid dispensing opening, having at least one end cap opening formed inside the end cap, A gas-sterilizable syringe comprising: disposed within the end cap; at least one end cap opening; and a gas-permeable barrier located between the first fluid dispensing opening and the second fluid dispensing opening of the respective first and second syringe barrels.

[0365] (11) A fluid material comprising a first part and a second part configured to be mixed together, The first portion of the fluid material is disposed within the first fluid chamber of the first syringe barrel. The second portion of the fluid material is disposed within the second fluid chamber of the second syringe barrel. A gas-sterilizable syringe according to Embodiment 10, wherein the gas-permeable barrier covers the first fluid dispensing opening and the second fluid dispensing opening of the first and second syringe barrels, and the gas-permeable barrier allows sterilization gas to pass through the first and second fluid dispensing openings, while preventing the first and second portions of the fluid material from passing through the first and second fluid dispensing openings. (12) The gas-sterilizable syringe according to Embodiment 11, wherein the end cap comprises a hub, the hub engages with the distal end wall of the dual-barrel syringe to form an airtight seal between the end cap hub and the distal end wall of the dual-barrel syringe. (13) The end cap hub has a proximal end that is open to receive the first fluid dispensing opening and the second fluid dispensing opening, and a distal end that is closed by a distal end wall including the at least one end cap opening, The end cap includes at least one radially extending projection that extends outward from the outer surface of the end cap hub, A gas-sterilizable syringe according to Embodiment 12, wherein the dual-barrel syringe includes at least one fixing flange protruding from the distal end wall of the dual-barrel syringe, the at least one fixing flange configured to engage with at least one radially extending projection of the end cap hub to releasably secure the end cap to the distal end wall of the dual-barrel syringe. (14) The applicator tip further comprises an applicator tip configured to extrude the fluid material from the distal end of the dual-barrel syringe, the applicator tip comprising a dispensing tube having a proximal end and a distal end, an applicator tip connector fixed to the proximal end of the dispensing tube, and a static mixer disposed within the dispensing tube, A gas-sterilizable syringe according to Embodiment 13, wherein the applicator tip connector has at least one radially extending projection, the projection being configured to engage with at least one fixing flange protruding from the distal end wall of the dual-barrel syringe in order to releasably secure the applicator tip to the distal end wall of the dual-barrel syringe. (15) The gas-sterilizable syringe according to Embodiment 11, wherein the gas-permeable barrier is permeable to the sterilization gas and impermeable to the first and second portions of the fluid material.

[0366] (16) A gas-sterilizable syringe according to Embodiment 15, wherein the gas-permeable barrier has closed-cell porosity configured to allow the sterilization gas to enter and exit during a sterilization procedure and to prevent the first and second portions of the fluid material from passing through the gas-permeable barrier. (17) A syringe that can be sterilized by gas, A dual-barrel syringe comprising a first syringe barrel and a second syringe barrel, The first syringe barrel includes a first fluid chamber and a first fluid dispensing opening located at the distal end of the first syringe barrel. The second syringe barrel includes a second fluid chamber and a second fluid dispensing opening located at the distal end of the second syringe barrel. A first portion of the fluid material is disposed within the first fluid chamber of the first syringe barrel. A dual-barrel syringe in which the second portion of the fluid material is disposed within the second fluid chamber of the second syringe barrel, A dual barrel plunger assembled with the dual barrel syringe, comprising a first plunger disposed in the first fluid chamber of the first syringe barrel and a second plunger disposed in the second fluid chamber of the second syringe barrel, An end cap, releasably fixed to the distal end of the dual-barrel syringe, for covering the first fluid dispensing opening and the second fluid dispensing opening located at the distal ends of the respective first and second syringe barrels, The end cap has at least one end cap opening formed inside, A gas-sterilizable syringe comprising: a gas-permeable barrier disposed within the end cap, located between the at least one end cap opening and the first and second fluid dispensing openings located at the distal ends of the respective first and second syringe barrels, the gas-permeable barrier being permeable to sterilization gas and impermeable to the fluid material, allowing the sterilization gas to pass through the first and second fluid dispensing openings while preventing the first and second portions of the fluid material from passing through the gas-permeable barrier. (18) The end cap comprises a central hub, the central hub engages with the distal end wall of the dual barrel syringe to form an airtight seal between the end cap hub and the distal end wall of the dual barrel syringe, The end cap has a central hub which is open to receive the first fluid dispensing opening and the second fluid dispensing opening, and a distal end which is closed by a distal end wall which includes the at least one end cap opening. The end cap includes at least one radially extending projection that extends outward from the outer surface of the central hub of the end cap, A gas-sterilizable syringe according to Embodiment 17, wherein the dual-barrel syringe includes at least one fixed flange, the at least one fixed flange protruding from the distal end wall of the dual-barrel syringe, and the end cap is configured to engage with at least one radially extending projection of the end cap to releasably secure the end cap to the distal end wall of the dual-barrel syringe. (19) The first syringe barrel has a cylindrical outer wall that surrounds the first fluid chamber and extends to the distal end of the first syringe barrel, At least one first ventilation opening formed in the cylindrical outer wall of the first syringe barrel, A first one-way plunger stopper is formed on the inner surface of the cylindrical outer wall of the first syringe barrel and is located between the at least one first vent hole and the distal end of the first syringe barrel, At least one second ventilation opening formed in the cylindrical outer wall of the second syringe barrel, A gas-sterilizable syringe according to Embodiment 17, further comprising: a second one-way plunger stopper formed on the inner surface of the cylindrical outer wall of the second syringe barrel and located between the at least one second vent of the second syringe barrel and the distal end of the second syringe barrel. (20) The first plunger has a first plunger head located at the distal end of the first plunger, the first plunger head is in contact with the first unidirectional plunger stopper, and is located between the at least one first vent hole and the distal end of the first syringe barrel, A gas-sterilizable syringe according to Embodiment 19, wherein the second plunger has a second plunger head located at the distal end of the second plunger, the second plunger head being in contact with the second unidirectional plunger stopper, and located between the at least one second vent and the distal end of the second syringe barrel.

Claims

1. A syringe that can be sterilized by gas, A dual-barrel syringe comprising a first syringe barrel having a first fluid chamber and a first fluid dispensing opening, and a second syringe barrel having a second fluid chamber and a second fluid dispensing opening, A dual-barrel plunger comprising a first plunger disposed in the first fluid chamber of the first syringe barrel, and a second plunger disposed in the second fluid chamber of the second syringe barrel, An end cap, releasably fixed to the distal end of the dual-barrel syringe to cover the first fluid dispensing opening and the second fluid dispensing opening, having at least one end cap opening formed inside the end cap, Disposed within the end cap, the gas permeable barrier is located between the at least one end cap opening and the first fluid dispensing opening and the second fluid dispensing opening of the first syringe barrel and the second syringe barrel, respectively. A fluid material comprising a first part and a second part configured to be mixed together, The first portion of the fluid material is disposed within the first fluid chamber of the first syringe barrel. The second portion of the fluid material is disposed within the second fluid chamber of the second syringe barrel. The gas permeable barrier covers the first fluid dispensing opening and the second fluid dispensing opening of the first syringe barrel and the second syringe barrel, and the gas permeable barrier allows sterile gas to pass through the first fluid dispensing opening and the second fluid dispensing opening, while preventing the first and second portions of the fluid material from passing through the first and second fluid dispensing openings. A gas-sterilizable syringe wherein the gas-permeable barrier is permeable to the sterilization gas and impermeable to the first and second portions of the fluid material.

2. The gas-sterilizable syringe according to claim 1, wherein the end cap comprises a hub, the hub engages with the distal end wall of the dual-barrel syringe to form an airtight seal between the hub and the distal end wall of the dual-barrel syringe.

3. The hub has a proximal end that is open to receive the first fluid dispensing opening and the second fluid dispensing opening, and a distal end that is closed by a distal end wall including the at least one end cap opening. The end cap includes at least one radially extending projection that extends outward from the outer surface of the hub, The gas-sterilizable syringe according to claim 2, wherein the dual-barrel syringe includes at least one fixing flange protruding from the distal end wall of the dual-barrel syringe, the at least one fixing flange configured to engage with at least one radially extending projection of the hub to releasably secure the end cap to the distal end wall of the dual-barrel syringe.

4. The gas-sterilizable syringe further comprises an applicator tip configured to extrude the fluid material from the distal end of the dual-barrel syringe, the applicator tip comprising a dispensing tube having a proximal end and a distal end, an applicator tip connector fixed to the proximal end of the dispensing tube, and a static mixer disposed within the dispensing tube, The gas-sterilizable syringe according to claim 3, wherein the applicator tip connector has at least one radially extending projection, the projection being configured to engage with at least one fixing flange protruding from the distal end wall of the dual-barrel syringe in order to releasably secure the applicator tip to the distal end wall of the dual-barrel syringe.

5. A gas-sterilizable syringe according to claim 1, wherein the gas-permeable barrier has closed-cell porosity configured to allow the sterilization gas to enter and exit during the sterilization procedure, and to prevent the first and second portions of the fluid material from passing through the gas-permeable barrier.

6. A syringe that can be sterilized by gas, A dual-barrel syringe comprising a first syringe barrel and a second syringe barrel, The first syringe barrel includes a first fluid chamber and a first fluid dispensing opening located at the distal end of the first syringe barrel. The second syringe barrel includes a second fluid chamber and a second fluid dispensing opening located at the distal end of the second syringe barrel. A first portion of the fluid material is disposed within the first fluid chamber of the first syringe barrel. A dual-barrel syringe in which the second portion of the fluid material is disposed within the second fluid chamber of the second syringe barrel, A dual barrel plunger assembled with the dual barrel syringe, comprising a first plunger disposed in the first fluid chamber of the first syringe barrel and a second plunger disposed in the second fluid chamber of the second syringe barrel, An end cap, releasably fixed to the distal end of the dual-barrel syringe, for covering the first fluid dispensing opening and the second fluid dispensing opening located at the distal ends of the first and second syringe barrels, respectively, the end cap having at least one end cap opening formed inside; A gas permeable barrier, disposed within the end cap, located between the at least one end cap opening and the first and second fluid dispensing openings located at the distal ends of the first and second syringe barrels, respectively, and permeable to sterilization gas and impermeable to the fluid material, allowing the sterilization gas to pass through the first and second fluid dispensing openings while preventing the first and second portions of the fluid material from passing through the gas permeable barrier, is provided, The end cap comprises a central hub, the central hub engages with the distal end wall of the dual-barrel syringe to form an airtight seal between the central hub and the distal end wall of the dual-barrel syringe, The end cap has a central hub which is open to receive the first fluid dispensing opening and the second fluid dispensing opening, and a distal end which is closed by a distal end wall which includes the at least one end cap opening. The end cap includes at least one radially extending projection that extends outward from the outer surface of the central hub of the end cap, A gas-sterilizable syringe comprising a dual-barrel syringe including at least one fixed flange, the at least one fixed flange protruding from the distal end wall of the dual-barrel syringe, and configured to engage with at least one radially extending projection of the end cap to releasably secure the end cap to the distal end wall of the dual-barrel syringe.

7. A syringe that can be sterilized by gas, A dual-barrel syringe comprising a first syringe barrel and a second syringe barrel, The first syringe barrel includes a first fluid chamber and a first fluid dispensing opening located at the distal end of the first syringe barrel. The second syringe barrel includes a second fluid chamber and a second fluid dispensing opening located at the distal end of the second syringe barrel. A first portion of the fluid material is disposed within the first fluid chamber of the first syringe barrel. A dual-barrel syringe in which the second portion of the fluid material is disposed within the second fluid chamber of the second syringe barrel, A dual barrel plunger assembled with the dual barrel syringe, comprising a first plunger disposed in the first fluid chamber of the first syringe barrel and a second plunger disposed in the second fluid chamber of the second syringe barrel, An end cap, releasably fixed to the distal end of the dual-barrel syringe, for covering the first fluid dispensing opening and the second fluid dispensing opening located at the distal ends of the first and second syringe barrels, respectively, the end cap having at least one end cap opening formed inside; A gas permeable barrier, disposed within the end cap, located between the at least one end cap opening and the first and second fluid dispensing openings located at the distal ends of the first and second syringe barrels, respectively, and permeable to sterilization gas and impermeable to the fluid material, allowing the sterilization gas to pass through the first and second fluid dispensing openings while preventing the first and second portions of the fluid material from passing through the gas permeable barrier, is provided, The aforementioned gas-sterilizable syringe, The first syringe barrel has a cylindrical outer wall that surrounds the first fluid chamber and extends to the distal end of the first syringe barrel, At least one first ventilation opening formed in the cylindrical outer wall of the first syringe barrel, A first one-way plunger stopper is formed on the inner surface of the cylindrical outer wall of the first syringe barrel and is located between the at least one first ventilation opening and the distal end of the first syringe barrel, At least one second ventilation opening formed in the cylindrical outer wall of the second syringe barrel, A second one-way plunger stopper is formed on the inner surface of the cylindrical outer wall of the second syringe barrel and is located between the at least one second ventilation opening of the second syringe barrel and the distal end of the second syringe barrel, A gas-sterilizable syringe with additional features.

8. The first plunger has a first plunger head located at the distal end of the first plunger, the first plunger head is in contact with the first unidirectional plunger stopper, and is located between the at least one first ventilation opening and the distal end of the first syringe barrel, The gas-sterilizable syringe according to claim 7, wherein the second plunger has a second plunger head located at the distal end of the second plunger, the second plunger head is in contact with the second unidirectional plunger stopper, and is located between the at least one second ventilation opening and the distal end of the second syringe barrel.

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