Gas Sterilizable Syringes Having Apertures Covered by Gas Permeable Barriers for Enabling Ingress and Egress of Sterilization Gases While Preventing Leakage of Flowable Materials

Abstract

A gas sterilizable syringe includes an enclosure having walls that define a fluid chamber. A flowable material is disposed within the fluid chamber of the enclosure. A plunger is assembled with the enclosure and is moveable toward a distal end of the enclosure for dispensing the flowable material. One or more apertures are formed in at least one of the walls of the enclosure. A gas permeable barrier covers at least one of the apertures formed in at least one of the walls of the enclosure for enabling sterilization gases 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 aperture. The gas permeable barrier is permeable to the sterilization gases and impermeable to the flowable material disposed within the fluid chamber of the enclosure.

Claims

1. A gas sterilizable syringe comprising: an enclosure having walls that define a fluid chamber; a flowable material disposed within said fluid chamber of said enclosure; a plunger assembled with said enclosure and being moveable toward a distal end of said enclosure for dispensing said flowable material from said enclosure; one or more apertures formed in at least one of said walls of said enclosure; a gas permeable barrier covering at least one of said apertures formed in the at least one of said walls of said enclosure for enabling sterilization gases to pass through the at least one of said apertures covered by said gas permeable barrier while preventing said flowable material from passing through the at least one of said apertures covered by said gas permeable barrier.

2. The gas sterilizable syringe as claimed in claim 1, wherein said gas permeable barrier that covers the at least one of said apertures formed in the at least one of said walls of said enclosure is permeable to said sterilization gases and impermeable to said flowable material disposed within said fluid chamber of said enclosure.

3. The gas sterilizable syringe as claimed in claim 2, wherein said gas permeable barrier has a closed porosity configured to enable ingress and egress of said sterilization gases during a sterilization procedure and to prevent said flowable material from passing through said gas permeable barrier.

4. The gas sterilizable syringe as claimed in claim 1, wherein the one or more apertures formed in the at least one of said walls of said enclosure comprise a plurality of apertures formed in the at least one of said walls of said enclosure, and wherein said gas permeable barrier comprises a plurality of gas permeable bodies filling each of the respective plurality of apertures formed in the at least one of said walls of said enclosure.

5. The gas sterilizable syringe as claimed in claim 4, wherein said plurality of gas permeable bodies filling each of the respective plurality of apertures are bonded to the at least one of said walls of said enclosure.

6. The gas sterilizable syringe as claimed in claim 1, wherein said gas permeable barrier is made of a material selected from the group consisting of silicone, room temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), high consistency rubber (HCR), and synthetic flashspun high-density polyethylene fibers.

7. The gas sterilizable syringe as claimed in claim 1, wherein said sterilization gases includes ethylene oxide, and said flowable material is selected from the group consisting of liquids and topical skin adhesives including silicone-based topical skin adhesives.

8. The gas sterilizable syringe as claimed in claim 1, wherein said enclosure comprises: a syringe barrel that surrounds said fluid chamber; a dispensing opening located at a distal end of said syringe barrel; a plunger moveable toward the distal end of said syringe barrel for dispensing said flowable material via said dispensing opening located at the distal end of said syringe barrel; said gas permeable barrier covering said dispensing opening for enabling said sterilization gases to pass through said dispensing opening while preventing said flowable material from passing through said dispensing opening.

9. The gas sterilizable syringe as claimed in claim 8, further comprising: an end cap secured to the distal end of said syringe barrel and covering said dispensing opening; one or more end cap openings formed in said end cap for enabling said sterilization gases to pass through said end cap; said gas permeable barrier being disposed inside said end cap and being located between said one or more end cap openings and said dispensing opening at the distal end of said syringe barrel; said end cap having a central hub that engages a distal end wall of said syringe barrel for forming an airtight seal between said central hub of said end cap and the distal end wall of said syringe barrel.

10. A gas sterilizable syringe comprising: a dual barrel syringe including 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 including a first plunger disposed within said first fluid chamber of said first syringe barrel and a second plunger disposed within said second fluid chamber of said second syringe barrel; an end cap releasably secured to a distal end of said dual barrel syringe for covering said first and second fluid dispensing openings, said end cap having at least one end cap opening formed therein; a gas permeable barrier disposed within said end cap and being located between said at least one end cap opening and said first and second fluid dispensing openings of said respective first and second syringe barrels.

11. The gas sterilizable syringe as claimed in claim 10, further comprising: a flowable material including a first part and a second part that are configured for being mixed together; said first part of said flowable material being disposed within said first fluid chamber of said first syringe barrel; said second part of said flowable material being disposed within said second fluid chamber of said second syringe barrel; said gas permeable barrier covering said first and second fluid dispensing openings of said first and second syringe barrels, wherein said gas permeable barrier enables sterilization gases to pass through said first and second fluid dispensing openings while preventing said first and second parts of said flowable material from passing through said first and second fluid dispensing openings.

12. The gas sterilizable syringe as claimed in claim 11, wherein said end cap comprises a hub that engages a distal end wall of said dual barrel syringe for forming an airtight seal between said end cap hub and the distal end wall of said dual barrel syringe.

13. The gas sterilizable syringe as claimed in claim 12, further comprising: said end cap hub having a proximal end that is open for receiving said first and second fluid dispensing openings and a distal end that is closed by a distal end wall that includes said at least one end cap opening; said end cap including at least one radially extending projection that extends outwardly from an outer surface of said end cap hub; said dual barrel syringe including at least one securing flange projecting from the distal end wall of said dual barrel syringe, wherein said at least one securing flange is configured to engage said at least one radially extending projection of said end cap hub for releasably securing said end cap to the distal end wall of said dual barrel syringe.

14. The gas sterilizable syringe as claimed in claim 13, further comprising: an applicator tip configured for expressing said flowable material from the distal end of said dual barrel syringe, said applicator tip including a dispensing tube having a proximal end and a distal end, an applicator tip connector secured to the proximal end of said dispensing tube, and a static mixer disposed within said dispensing tube; said applicator tip connector having at least one radially extending projection that is configured to engage said at least one securing flange projecting from the distal end wall of said dual barrel syringe for releasable securing said applicator tip to the distal end wall of said dual barrel syringe.

15. The gas sterilizable syringe as claimed in claim 11, wherein said gas permeable barrier is permeable to said sterilization gases and impermeable to said first and second parts of said flowable material.

16. The gas sterilizable syringe as claimed in claim 15, wherein said gas permeable barrier has a closed cell porosity configured to enable ingress and egress of said sterilization gases during a sterilization procedure and to block passage of said first and second parts of said flowable material through said gas permeable barrier.

17. A gas sterilizable syringe comprising: a dual barrel syringe including a first syringe barrel and a second syringe barrel; said first syringe barrel including a first fluid chamber and a first fluid dispensing opening located at a distal end of said first syringe barrel; said second syringe barrel including a second fluid chamber and a second fluid dispensing opening located at a distal end of said second syringe barrel; a first part of a flowable material disposed within said first fluid chamber of said first syringe barrel; a second part of said flowable material disposed within said second fluid chamber of said second syringe barrel; a dual barrel plunger assembled with said dual barrel syringe, said dual barrel plunger including a first plunger disposed within said first fluid chamber of said first syringe barrel and a second plunger disposed within said second fluid chamber of said second syringe barrel; an end cap releasably secured to a distal end of said dual barrel syringe for covering said first and second fluid dispensing openings located at the distal ends of said respective first and second syringe barrels; said end cap having at least one end cap opening formed therein; a gas permeable barrier disposed within said end cap and being located between said at least one end cap opening and said first and second fluid dispensing openings located at the distal ends of said respective first and second syringe barrels, wherein said gas permeably barrier is permeable to sterilization gases and impermeable to said flowable material for enabling said sterilization gases to pass through said first and second fluid dispensing openings while preventing said first and second parts of said flowable material from passing through said gas permeable barrier.

18. The gas sterilizable syringe as claimed in claim 17, further comprising: said end cap comprising a central hub that engages a distal end wall of said dual barrel syringe for forming an airtight seal between said end cap hub and the distal end wall of said dual barrel syringe. said central hub of said end cap having a proximal end that is open for receiving said first and second fluid dispensing openings and a distal end that is closed by a distal end wall that includes said at least one end cap opening; said end cap including at least one radially extending projection that extends outwardly from an outer surface of said central hub of said end cap; said dual barrel syringe including at least one securing flange projecting from the distal end wall of said dual barrel syringe that is configured to engage said at least one radially extending projection of said end cap for releasably securing said end cap to the distal end wall of said dual barrel syringe.

19. The gas sterilizable syringe as claimed in claim 17, further comprising: said first syringe barrel having a cylindrical-shaped outer wall that surrounds said first fluid chamber and that extends to the distal end of said first syringe barrel; at least one first air vent opening formed in said cylindrical-shaped outer wall of said first syringe barrel; a first one-way plunger stop formed in an inner surface of said cylindrical-shaped outer wall of said first syringe barrel and being located between said at least one first air vent and the distal end of said first syringe barrel; at least one second air vent opening formed in said cylindrical-shaped outer wall of said second syringe barrel; a second one-way plunger stop formed in an inner surface of said cylindrical-shaped outer wall of said second syringe barrel and being located between said at least one second air vent of said second syringe barrel and the distal end of said second syringe barrel.

20. The gas sterilizable syringe as claimed in claim 19, further comprising: said first plunger having a first plunger head located at a distal end of said first plunger, said first plunger head being in contact with said first one-way plunger stop and being located between said at least one first air vent and the distal end of said first syringe barrel; said second plunger having a second plunger head located at a distal end of said second plunger, said second plunger head being in contact with said second one-way plunger stop and being located between said at least one second air vent and the distal end of said second syringe barrel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0208] FIG. 1 is a schematic view of a gas sterilizable syringe including a syringe barrel having a distal end wall, a dispensing tip, and end cap, and a syringe plunger, the gas sterilizable syringe having a plurality of micro-apertures formed therein for enabling gas sterilization of the syringe, in accordance with one embodiment of the present patent application.

[0209] FIG. 2 shows a method of making a gas sterilizable syringe having a plurality of micro-apertures for enabling gas sterilization of the gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0210] FIG. 3A is a schematic view of a gas sterilizable syringe including a syringe barrel and a syringe plunger, the syringe barrel having a plurality of micro-apertures formed therein for enabling gas sterilization of the gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0211] FIG. 3B shows the gas sterilizable syringe of FIG. 3A with an end cap removed, and the syringe plunger moved to a location that is distal to the location of the syringe plunger shown in FIG. 3A.

[0212] FIG. 4 is a cross-sectional view of a syringe barrel of a gas sterilizable syringe, the syringe barrel including an outer wall having a plurality of blind micro-apertures formed therein for enabling gas sterilization of the gas sterilizable syringe while preventing a viscous, flowable material from leaking through the blind micro-apertures, in accordance with one embodiment of the present patent application.

[0213] FIG. 5A is a schematic view of a gas sterilizable syringe including a syringe barrel having a plurality of micro-apertures formed therein for enabling gas sterilization of the gas sterilizable syringe, the gas sterilizable syringe including a protective sleeve that is slidable over an outer surface of the syringe barrel for selectively covering the plurality of micro-apertures, in accordance with one embodiment of the present patent application.

[0214] FIG. 5B shows the gas sterilizable syringe of FIG. 5A with the protective sleeve in an extended position for covering the plurality of micro-apertures formed in the syringe barrel, in accordance with one embodiment of the present patent application.

[0215] FIG. 6 is a schematic view of a gas sterilizable syringe including a syringe barrel and a dispensing tip having a plurality of micro-apertures formed therein, the gas sterilizable syringe including a first microporous sleeve covering the micro-apertures formed in the syringe barrel and a second microporous sleeve covering the micro-apertures formed in the dispensing tip, in accordance with one embodiment of the present patent application.

[0216] FIG. 7 is a schematic view of a gas sterilizable syringe including a syringe barrel and a dispensing tip having a plurality of micro-apertures formed therein, and microporous sleeves covering inner surfaces of the syringe barrel and the dispensing tip, in accordance with one embodiment of the present patent application.

[0217] FIG. 8 is a schematic view of a gas sterilizable syringe including a syringe barrel, a distal end wall partially closing a distal end of the syringe barrel, a dispensing tip, an end cap covering a distal end of the dispensing tip, and a syringe plunger having a piston, the gas sterilizable syringe including a plurality of micro-apertures formed in the syringe barrel, the distal end wall, the end cap, and the piston that are covered by respective microporous sleeves, in accordance with one embodiment of the present patent application.

[0218] FIG. 9 is a schematic view of a gas sterilizable syringe system including a first syringe barrel having a plurality of micro-apertures formed therein and a second syringe barrel having a plurality of micro-apertures formed therein for enabling gas sterilization of the first and second syringe barrels, in accordance with one embodiment of the present patent application.

[0219] FIG. 10A is a schematic view of a subassembly of a gas sterilizable syringe including a syringe barrel having a distal end wall, a dispensing tip, and end cap, and a syringe plunger, the gas sterilizable syringe having a plurality of apertures formed therein, in accordance with one embodiment of the present patent application.

[0220] FIG. 10B is a schematic view of a gas sterilizable syringe including the subassembly of FIG. 10A, the gas sterilizable syringe having gas permeable barriers filling the apertures for enabling gas sterilization of the gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0221] FIG. 11A is a schematic view of a subassembly of a gas sterilizable syringe including a syringe barrel having a plurality of apertures formed therein, in accordance with one embodiment of the present patent application.

[0222] FIG. 11B shows the syringe barrel of FIG. 11A having gas permeable barriers filling the apertures for enabling gas sterilization of a gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0223] FIG. 12 illustrates a method of making a gas sterilizable syringe having apertures and gas permeable barriers that fill the apertures for enabling gas sterilization of the gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0224] FIG. 13 is an exploded view of a gas sterilizable syringe including a double barrel syringe, a double barrel plunger, an end cap having end cap openings, and a gas permeable barrier, in accordance with one embodiment of the present patent application.

[0225] FIG. 14 shows a top view of the gas permeable barrier shown in FIG. 13.

[0226] FIG. 15 shows a distal end view of a gas sterilizable syringe including a double barrel syringe, an end cap having end cap openings secured to a distal end of the double barrel syringe, and a gas permeable barrier disposed within the end cap, in accordance with one embodiment of the present patent application.

[0227] FIG. 16A is an exploded view of a gas sterilizable syringe including a double barrel syringe, a double barrel plunger having first and second plungers, plunger seals secured to the distal ends of the respective first and second plungers, and an end cap securable over the distal end of the double barrel syringe, in accordance with one embodiment of the present patent application.

[0228] FIG. 16B shows a side view of the gas sterilizable syringe shown in FIG. 16A after the double barrel syringe, the double barrel plunger having the plunger seals secured to the distal ends of the respective first and second plungers, and the end cap have been assembly together, and with the syringe barrels filled with a flowable material.

[0229] FIG. 17 is an exploded view of a gas sterilizable syringe including a double barrel syringe, an end cap having end cap openings, a gas permeable barrier located at a distal end of the double barrel syringe, a double barrel plunger having first and second plungers insertable into the double barrel syringe, first and second gas permeable plunger seals securable to the distal ends of the respective first and second plungers, and a mixing and dispensing tip, in accordance with one embodiment of the present patent application.

[0230] FIG. 18A is a perspective view of a gas sterilizable syringe including a double barrel syringe, a double barrel plunger, and an end cap having end cap openings, in accordance with one embodiment of the present patent application.

[0231] FIG. 18B is a front view of the gas sterilizable syringe shown in FIG. 18A.

[0232] FIG. 19 is an exploded view of the gas sterilizable syringe shown in FIGS. 18A and 18B including the double barrel syringe, the double barrel plunger, the end cap having end cap openings, and a gas permeable barrier configured for being disposed within the end cap, in accordance with one embodiment of the present patent application.

[0233] FIG. 20 is another exploded view of the gas sterilizable syringe shown in FIG. 19.

[0234] FIG. 21A is a perspective view of a distal end of the double barrel plunger shown in FIG. 19, the double barrel plunger including a first plunger and a second plunger.

[0235] FIG. 21B is a front view of the double barrel plunger shown in FIG. 21A.

[0236] FIG. 22A is a magnified view of the distal ends of the first and second plungers of the double barrel plunger shown in FIG. 21B.

[0237] FIG. 22B is a perspective view of the distal ends of the first and second plungers of the double barrel plunger shown in FIGS. 21A and 22A.

[0238] FIG. 23 is a cross-sectional view of the double barrel syringe shown in FIG. 19, the double barrel syringe including a first syringe barrel and a second syringe barrel.

[0239] FIG. 24 is a magnified view of a midsection of the first syringe barrel shown in FIG. 23.

[0240] FIG. 25 is a cross-sectional view of the double barrel syringe shown in FIG. 19.

[0241] FIG. 26 is a cross-sectional view of the double barrel plunger shown in FIG. 19.

[0242] FIG. 27 is a cross-sectional view of the gas sterilizable syringe shown in FIG. 18B.

[0243] FIG. 28A is a magnified view of a midsection of the gas sterilizable syringe shown in FIG. 18B.

[0244] FIG. 28B is a cross-sectional view of a midsection of a first syringe barrel of a gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0245] FIG. 29A is a perspective view of the end cap of the gas sterilizable syringe shown in FIGS. 18A and 18B.

[0246] FIG. 29B is another perspective view of the end cap shown in FIG. 29B.

[0247] FIG. 29C is a front view of the end cap shown in FIGS. 29A and 29B.

[0248] FIG. 29D is a top view of the end cap shown in FIGS. 29A-29C.

[0249] FIG. 30 is a cross-sectional view of the end cap and the gas permeable barrier shown in FIG. 19.

[0250] FIG. 31 shows the end cap of FIG. 30 with the gas permeable barrier disposed inside the end cap, in accordance with one embodiment of the present patent application.

[0251] FIG. 32 shows a cross-sectional view of a distal end of a gas sterilizable syringe including a double barrel syringe, a double barrel plunger, an end cap secured to the distal end of the double barrel syringe, and a gas permeable barrier, in accordance with one embodiment of the present patent application.

[0252] FIG. 33 shows a top view of a subassembly of a gas sterilizable syringe including a double barrel syringe and a double barrel plunger, in accordance with one embodiment of the present patent application.

[0253] FIG. 34A shows a perspective view of a multi-function connector that is secured over the distal end of the double barrel syringe shown in FIG. 33, in accordance with one embodiment of the present patent application.

[0254] FIG. 34B shows a distal end view of the multi-function connector shown in FIG. 34A.

[0255] FIG. 35 shows an exploded view of the multi-function connector of FIGS. 34A and 34B, first and second gas permeable barriers that are insertable into D-shaped openings of the multi-function connector, and an end cap securable to an externally threaded post of the multi-function connector, in accordance with one embodiment of the present patent application.

[0256] FIG. 36 shows the end cap of FIG. 35 secured over the externally threaded post of the multi-function connector of FIG. 35.

[0257] FIG. 37 shows a perspective view of a plurality of gas sterilizable syringes, each syringe having the multi-function connector and the end cap of FIG. 36 secured to a distal end thereof.

[0258] FIG. 38 shows a side view of a mixing and dispensing tip of a gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0259] FIG. 39 shows the mixing and dispensing tip of FIG. 38 secured to a distal end of a gas sterilizable syringe, in accordance with one embodiment of the present patent application.

[0260] FIG. 40 shows a distal end view of a multi-function connector for a gas permeable syringe, the multi-function connector having first and second D-shaped openings that are adapted to receive gas permeable barriers, in accordance with one embodiment of the present patent application.

[0261] FIG. 41 shows a distal end view of a prior art connector for a double barrel syringe.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0262] Referring to FIG. 1, in one embodiment, a gas sterilizable syringe 100 preferably includes a syringe barrel 102 and a syringe plunger 104 that is configured for being assembled with the syringe barrel. The syringe barrel 102 preferably has a fluid chamber 105 that is configured to receive a flowable material such as a precursor or component of a tissue adhesive. In one embodiment, the flowable material is a viscous, flowable material having a relatively high viscosity of about 1,000-100,000 centipoise, more preferably about 2,000-75,000 centipoise, and even more preferably about 30,000-60,000 centipoise. In one embodiment, the syringe plunger 104 may be depressed in the distal direction DIR1 for dispensing the viscous, flowable material. The gas sterilizable syringe 100 may be made of a variety of materials including polymeric materials, glass, and rubber, and/or a combination of the afore-mentioned materials.

[0263] In one embodiment, the viscous, flowable material may comprise or be a precursor of a two-part silicone adhesive formulation as disclosed in U.S. patent application Ser. No. 16/885,361, filed on May 28, 2020 (Attorney Docket No. ETH6070USNP1), U.S. patent application Ser. No. 17/327,940, filed on May 24, 2021 (Attorney Docket No. ETH6070USCIP1), U.S. patent application Ser. No. 16/885,366, filed on May 28, 2020 (Attorney Docket No. ETH6084USNP1), and U.S. patent application Ser. No. 17/327,952, filed on May 24, 2021 (Attorney Docket No. ETH6084USCIP1), the disclosures of which are hereby incorporated by reference herein.

[0264] In one embodiment, the syringe barrel 102 preferably has a proximal end 106 that is open and distal end 108 that is partially closed by a distal end wall 110. The gas sterilizable syringe 100 preferably includes a dispensing tip 112 that projects distally from the distal end wall 110. The dispensing tip 112 has a conduit 114 that provides a flow path for dispensing the flowable material that is disposed within the fluid chamber 105 of the syringe barrel 102. An opening at the distal end of the conduit 114 may be covered by an end cap 116. The end cap 116 may cover the distal end of the dispensing tip 112 during shipment and storage. The end cap 116 may be removed from the distal end of the dispensing tip 112 for dispensing the flowable material.

[0265] In one embodiment, the syringe plunger 104 preferably includes a piston 118 that is disposed inside the fluid chamber 105 of the syringe barrel 102. The piston 118 preferably has an outer perimeter that engages an 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 polymeric material. The plunger 104 preferably includes a plunger stem 120 having a distal end that is secured to a proximal side of the piston 118. In one embodiment, the plunger 104 preferably includes a thumb tab 122 that is desirably secured to a proximal end of the plunger stem 120. The thumb tab 122 may be depressed in the distal direction designated DIR1 for forcing 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, as the thumb tab 122 is depressed in the distal direction DIR1, a flowable material that has been pre-loaded into the fluid chamber 105 of the syringe barrel 102 may be forced to flow downstream into the conduit 114 of the dispensing tip 110 for being dispensed from an opening at the distal end of the dispensing tip 112.

[0266] In one embodiment, the syringe barrel 102 desirably has an outer wall 124 and a plurality of micro-apertures 126 may be formed (e.g., drilled, laser drilled, mechanically drilled) in the outer wall 124 of the syringe barrel 102. The micro-apertures 126 may be formed by using a laser device that laser drills the small openings. In one embodiment, the syringe barrel 102 has a length that extends along a longitudinal axis A.sub.1 and the micro-apertures 126 may extend along an axis A2 that is perpendicular to the longitudinal axis A.sub.1 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 A.sub.3 that is diagonal to and/or not perpendicular with the longitudinal axis A.sub.1.

[0267] In one embodiment, one or more micro-apertures 130 may extend through the piston 118 of the syringe plunger 104.

[0268] In one embodiment, one or more micro-apertures 132 may be formed in the distal end wall 110 of the syringe barrel 102. The micro-apertures 132 formed in the distal end wall 110 may extend along respective axes that are parallel with the longitudinal axis A.sub.1 of the syringe barrel 102. In other embodiments, however, the micro-apertures 132 formed in the distal end wall 110 may extend along respective axes that define an angle relative to the longitudinal axis A.sub.1 of the syringe barrel 102.

[0269] 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 that extends between the thumb tab 122 and the piston 118.

[0270] In one embodiment, one or more micro-apertures 134 may be formed in the end cap 116 that is secured over the distal end of the dispensing tip 112. In one embodiment, the end cap 116 may have micro-apertures 134 that extend along respective axes that are parallel with the longitudinal axis A.sub.1 of the syringe barrel 102. In one embodiment, the end cap 116 may have one or more micro-apertures 136 that extend along respective axes that are non-parallel (e.g., diagonal) with the longitudinal axis A.sub.1 of the syringe barrel 102.

[0271] The micro-apertures disclosed herein may be formed using a variety of techniques and methodologies. Referring to FIG. 2, in one embodiment, a laser device 125 may be utilized for forming the micro-apertures 126 in the outer wall 124 of the syringe barrel 102. In one embodiment, the laser device 125 preferably generates laser light 135 that contacts the outer wall 124 of the syringe barrel 102 for laser drilling the micro-apertures 126, which extend completely through the outer wall 124 (i.e., from an outer surface 138 to an inner surface 140 of the outer wall 124). In one embodiment, the laser device 125 may be configured for forming one or more micro-apertures that are perpendicular to the longitudinal axis A.sub.1 of the syringe barrel. The laser device 125 may also be programmed for forming one or more micro-apertures 128 that are parallel, diagonal and/or non-perpendicular to the longitudinal axis A.sub.1 of the syringe barrel 102.

[0272] In one embodiment, the laser device 125 may be utilized for forming one or more micro-apertures 130 in the piston 118 of the plunger 104, one or more micro-apertures 132 in the distal end wall 110 of the syringe barrel 102, and/or one or more micro-apertures 134, 136, in the end cap 116 that is secured over the distal end of the dispensing tip 112. The laser device may also be used for laser drilling micro-apertures in the dispensing tip 112.

[0273] Other methods may be used for forming micro-apertures in one or more components of a gas sterilizable syringe including using mechanical drills, using heated probes, and using water jets.

[0274] Referring to FIG. 3A, in one embodiment, a 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 a proximal end 206 that is open 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 that is configured to receive a viscous, flowable material (not shown). The syringe 200 has a distal end wall 210 and a dispensing tip 212 that projects from the distal end wall 210. A distal end of the dispensing tip 212 is covered by an end cap 216 that may be removed for dispensing the viscous, flowable material.

[0275] In one embodiment, the syringe barrel 202 preferably has one or more micro-apertures 226 that are formed in the outer wall 224 of the syringe barrel 202 and that extend from the outer surface 238 to the inner surface 240 of the outer wall 224. In one embodiment, the one or more micro-apertures 226 are closer to the proximal end 206 of the syringe barrel 202 than the distal end 208 of the syringe barrel.

[0276] Referring to FIGS. 3A and 3B, in one embodiment, as a result of positioning the one or more micro-apertures 226 closer to the proximal end 206 than the distal end 208 of the outer wall 226 of the syringe barrel 202, the opportunity for the viscous, flowable material to leak through the one or more micro-apertures 226 as the plunger 204 is depressed in the distal direction DIR1 is greatly minimized. As shown in FIGS. 3A and 3B, at the start of a procedure for dispensing a flowable material (i.e., the position of the plunger 204 shown in FIG. 3A), after the end cap 216 (FIG. 3A) has been removed from the distal end of the dispensing tip 212, the piston 218 is located near the proximal end 206 of the outer wall 224 of the syringe barrel 202. As the syringe plunger 204 is depressed to start a dispensing procedure, the piston 218 moves distally (DIR1) beyond the one or more micro-apertures 226 formed in the syringe barrel. As a result, as a dispensing operation progresses, the piston 218 moves beyond the micro-apertures 226 and advances distally into a section of the outer wall 224 that has no micro-apertures, thereby minimizing the likelihood that the viscous, flowable material will be able to leak through the micro-apertures while providing for a continuous expression of the flowable material.

[0277] Referring to FIG. 4, in one embodiment, a gas sterilizable syringe 300 preferably includes a syringe barrel 302 having an outer wall 324 that extends along the longitudinal axis A.sub.1 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 that defines a fluid chamber 305 that is adapted to contain a viscous, flowable material 315 that is dispensed during operation of the syringe 300. In one embodiment, the syringe 300 preferably includes one or more micro-apertures 326 having blind openings that are formed in the outer wall 324 of the syringe barrel 302. The blind openings of the micro-apertures 326 do not extend completely through the outer wall 324 and do not reach the inner surface 340 of the outer wall 324, thereby leaving a thin membrane 335 formed of the outer wall 324 that extends between the closed ends of the blind openings of the micro-apertures and the inner surface 340 of the outer wall 324 of the syringe barrel 302.

[0278] In one embodiment, the micro-apertures 326, 328 preferably have inner diameters ID.sub.1 of about 0.1 microns to about 25 microns, and more preferably about one (1) micron. In one embodiment, the viscous, flowable material 315 disposed within the fluid chamber 305 preferably has a viscosity of about 1,000-100,000 centipoise, more preferably about 2,000-75,000 centipoise, and even more preferably about 30,000-60,000 centipoise. As a result, a sterilization gas (e.g., ethylene oxide) is able to pass through the micro-apertures 326, 328 and the membrane 335 for sterilizing inside the fluid chamber 305, however, during a dispensing operation, when the flowable material 315 is under positive pressure, the higher viscosity of the flowable material 315 prevents the flowable material 315 from leaking through the membrane 335 or out of the micro-apertures 326, 328.

[0279] In one embodiment, a first group of the micro-apertures 326 having blind openings may extend along respective axes that are perpendicular to the longitudinal axis A.sub.1 of the syringe barrel 302.

[0280] In one embodiment, a second group of the micro-apertures 328 having blind openings may extend along respective axes that are diagonal and/or not perpendicular to the longitudinal axis A.sub.1 of the syringe barrel 302.

[0281] Referring to FIG. 5A, in one embodiment, a gas sterilizable syringe 400 preferably includes a protective sleeve 442 that may be moved over a syringe barrel between a retracted position (FIG. 5A) for sterilizing the syringe and a viscous, flowable material loaded therein, and an extended position (FIG. 5B) for dispensing the viscous, flowable material. In one embodiment, the gas sterilizable syringe 400 desirably includes a syringe barrel 402, a plunger 404, a dispensing tip 412 projecting from the distal end 408 of the syringe barrel 402, and an end cap 416 that covers an opening at the distal end of the dispensing tip 412. In one embodiment, the syringe 400 preferably includes one or more micro-apertures 426 that are formed in the outer wall 424 of the syringe barrel 402 and that extend from the outer surface 438 to the inner surface 440 of the syringe barrel 402. The one or more micro-apertures 426 may have axes that are perpendicular to and/or non-perpendicular (e.g., extend diagonally) relative to the longitudinal axis A.sub.1 of the syringe barrel 402.

[0282] Referring to FIGS. 5A and 5B, in one embodiment, the protective sleeve 442, which may be made of a non-porous material, is adapted to slide over the outer surface 438 of the outer wall 424 of the syringe barrel 402, between the retracted position shown in FIG. 5A and the extended position shown in FIG. 5B. In the retracted position shown in FIG. 5A, the protective sleeve 442 does not cover the one or more micro-apertures 426 so that a sterilization gas (e.g., ethylene oxide) may be utilized for sterilizing the syringe 400 and a viscous, flowable material (not shown) disposed within the fluid chamber 405 of the syringe barrel 402. With the protective sleeve 442 retracted (FIG. 5A), the sterilization gases are able to pass through the micro-apertures 426 for sterilizing the syringe 400 including the viscous, flowable material within the fluid chamber 405.

[0283] In the position shown in FIG. 5B, the protective sleeve 442 has been moved into the extended position for covering the one or more micro-apertures 426 that are 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 the one or more micro-apertures 426 after sterilization and before dispensing the flowable material to seal the micro-apertures 426 to prevent the flowable material from leaking through the micro-apertures as it is being dispensed from the syringe 400. When the flowable material (not shown) is under positive pressure during a dispensing operation, the extended protective sleeve 442 (FIG. 5B) blocks the flowable material from leaking out of the micro-apertures 426.

[0284] Referring to FIG. 6, in one embodiment, a gas sterilizable syringe 500 preferably includes a syringe barrel 502 that defines a fluid chamber 505 adapted to receive a flowable material (e.g., a precursor of a tissue adhesive), a plunger 504 having a piston 518, a dispensing tip 512, and an end cap 516 that covers a dispensing opening at the distal end of the dispensing tip 512. In one embodiment, a plurality of micro-apertures 526 are formed 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 not permeable to the flowable material stored within the fluid chamber 505 of the syringe barrel 502, but which is permeable to sterilization gases (e.g., ethylene oxide) may be provided over the outer surface 538 of the outer wall 524 of the syringe barrel 502 to cover the micro-apertures 526 formed in the outer wall 524 of the syringe barrel.

[0285] In one embodiment, the gas sterilizable syringe 500 may include additional micro-apertures formed in other locations that are covered by one or more microporous sleeves. In one embodiment, the dispensing tip 512 of the syringe 500 may have one or more micro-apertures 546 formed therein that are covered by a dispensing tip microporous sleeve 548, which is similar in construction to the microporous sleeve 544 that covers the micro-apertures 526 formed in the syringe barrel 502.

[0286] The dispensing tip microporous sleeve 548 (e.g., a TYVEK® sleeve) is not permeable to the flowable material stored within the fluid chamber 505 of the syringe barrel 502 (to prevent leakage), but is permeable to sterilization gases (e.g., ethylene oxide). The dispensing tip microporous sleeve 548 may be wrapped around an outer surface of the dispensing tip 512 for covering the micro-apertures 526 formed in the outer wall of the dispensing tip. In one embodiment, a microporous material may line an inner surface of the dispensing tip.

[0287] Referring to FIG. 7, in one embodiment, a gas sterilizable syringe 600 preferably includes a syringe barrel 602, a plunger 604, and a dispensing tip 612 that projects from a distal end of syringe barrel 602. In one embodiment, the syringe 600 preferably includes a plurality of micro-apertures 626 that are formed in the outer wall 624 of the syringe barrel 602 and that extend from the outer surface 638 to the inner surface 640 of the outer wall 624 of the syringe barrel 602. The micro-apertures 626 are preferably in 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 lines the inner surface 640 of the outer wall 624 of the syringe barrel 602 to cover the micro-apertures 626 that extend through the outer wall 624 of the syringe barrel 602. The microporous sleeve 644 preferably defines an inner diameter ID.sub.2 that enables the piston 618 of the plunger 604 to slide over an inner surface 645 of the microporous sleeve 644 while preferably maintaining a fluid-tight seal with the inner surface of the microporous sleeve 644. In one embodiment, when the syringe plunger 604 is depressed in the distal direction DIR1 for dispensing a viscous, flowable material via the dispensing tip 612, the piston 618 preferably slides over the inner surface 645 of the microporous sleeve 644.

[0288] In one embodiment, the dispensing tip 612 preferably includes a plurality of micro-apertures 644 formed in an 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 in the dispensing tip 612. The second microporous sleeve 648 is not permeable to the flowable fluid stored within the fluid chamber 605 of the syringe barrel 602, however, the second microporous sleeve 644 is permeable to sterilizing gases (e.g., ethylene oxide) that may be utilized for sterilizing the syringe 600 and the flowable fluid disposed within the fluid chamber 605 of the syringe.

[0289] Referring to FIG. 8, in one embodiment, a 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 an opening at a distal end of dispensing tip 712. The syringe barrel 702 desirably has a proximal end 706 that is open for receiving the plunger 704 and a distal end 708 that is partially closed by a distal end wall 710.

[0290] In one embodiment, micro-apertures 726 are formed in the outer wall 724 of the syringe barrel 702. In one embodiment, a microporous sleeve 744 covers the outer surface 738 of the outer wall 724 of the syringe barrel 702 to cover the micro-apertures 726 formed in the outer wall 724 of the syringe barrel 702. The microporous sleeve 744 allows sterilizing gases to pass through the micro-apertures 726 for sterilizing the syringe 700 and a flowable material disposed therein while preventing the flowable material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 726.

[0291] In one embodiment, the distal end wall 710 preferably has one or more micro-apertures 732 formed therein. A microporous layer 748 preferably covers the micro-apertures 732 formed in the distal end wall 710. The microporous layer 748 allows sterilizing gases to pass through the micro-apertures 732 formed in the distal end wall 710 for sterilizing the syringe 700 and a flowable material disposed therein while preventing the flowable material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 732.

[0292] In one embodiment, the end cap 716 has one or more micro-apertures 734 formed therein and a microporous layer 752 covers the one or more micro-apertures 743 in the end cap 716. The microporous layer 752 allows sterilizing gases to pass through the micro-apertures 734 formed in the end cap 716 for sterilizing the syringe 700 and the flowable material while preventing flowable material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 734.

[0293] In one embodiment, the piston 718 of the syringe plunger 704 preferably has one or more micro-apertures 730 formed therein and a microporous layer 750 covers the one or more micro-apertures 730 formed in the piston 718. The microporous layer 750 allows sterilizing gases to pass through the micro-apertures 730 formed in the piston 718 for sterilizing the syringe 700 and the flowable material while preventing the flowable material disposed within the fluid chamber 705 of the syringe barrel 702 from leaking through the micro-apertures 730 of the piston 718.

[0294] Referring to FIG. 9, in one embodiment, a syringe system 800 for dispensing precursors of a tissue adhesive may include a first syringe barrel 802A containing a first precursor of a tissue adhesive having a plurality of micro-apertures 826A formed therein that extend from an outer surface to an inner surface of an outer wall 824A of the first syringe barrel 802A.

[0295] In one embodiment, the system 800 preferably includes a second syringe barrel 802B containing a second precursor of a tissue adhesive having a plurality of micro-apertures 826B formed therein that extend from an outer surface to an inner surface of an outer wall 824B of the second syringe barrel 802B.

[0296] In one embodiment, the syringe system 800 preferably includes a plunger 804 that enables the two flowable materials disposed in the respective first and second syringe barrel 802A, 802B to be simultaneously and/or near simultaneously dispensed from the dispensing tips 812A, 8128 of the respective first and second syringe barrels 802A, 802B. Upon being dispensed, the first and second precursors are preferably mixed and/or joined together to form a tissue adhesive.

[0297] In one embodiment, one or more of the gas sterilizable syringes disclosed herein may be sterilized by placing a syringe inside a pouch that is adapted to be used during a gas sterilization procedure. The pouch may have one or more non-porous panels (e.g., made of foil; made of a flexible polymer), and one or more porous panels (e.g., made of TYVEK® material) that allow sterilization gases to pass therethrough. The pouches may be sealed for sealing the syringes inside the pouches. After sealing the pouches, sterilization gases may pass through the one or more porous panels of the sealed pouches for sterilizing the syringe(s) disposed inside the sealed pouch. After sterilization, the one or more porous panels prevent bacteria and contaminants from passing therethrough to maintain the sterile state of the syringe(s).

[0298] Referring to FIG. 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 that is configured for being assembled with the syringe barrel. The syringe barrel 902 preferably defines a fluid chamber 905 that is configured to receive a flowable material such as a precursor or a component of a tissue adhesive (e.g., a silicone-based topical skin adhesive).

[0299] In one embodiment, the syringe barrel 902 preferably has a proximal end 906 that is open 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 that projects distally from the distal end wall 910. The dispensing tip 912 has a conduit 914 that provides a flow path for dispensing a flowable material (not shown). The flowable material may be disposed within the fluid chamber 905 of the syringe barrel 902. A 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 during shipment and storage of the gas sterilizable syringe 900. In one embodiment, the end cap 916 may be removed from the distal end of the dispensing tip 912 for dispensing and/or expressing the flowable material from the distal end of the syringe barrel 902.

[0300] In one embodiment, the syringe plunger 904 preferably includes a piston 918 (e.g., a plunger head) that may be disposed inside the fluid chamber 905 of the syringe barrel 902. The piston 918 preferably has an outer perimeter that engages an inner surface of the syringe barrel 902 to form a fluid-tight seal between the piston and the inner surface of the syringe barrel. In one embodiment, the piston 918 may be made of a variety of conventional materials including rubber and/or a polymer. The plunger 904 preferably includes a plunger stem 920 having a distal end that is secured to a proximal side of the piston 918. In one embodiment, the plunger 904 preferably includes a thumb tab 922 that is desirably secured to a proximal end of the plunger stem 920. The thumb tab 922 may be depressed in the distal direction designated DIR1 for forcing the piston 918 to slide distally within the fluid chamber 905 and toward the distal end wall 910 of the syringe barrel 902. In one embodiment, with the end cap 916 removed, as the thumb tab 922 is depressed in the distal direction DIR1, a flowable material that has been pre-loaded into the fluid chamber 905 of the syringe barrel 902 may be forced to flow downstream into the conduit 914 of the dispensing tip 912 for being expressed from the dispensing opening at the distal end of the dispensing tip 912.

[0301] 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 (e.g., drilled, lasered drilled, mechanically drilled) in the outer wall 924 of the syringe barrel 902.

[0302] In one embodiment, the gas sterilizable syringe 900 may include one or more apertures 930 that extend through the piston 918 of the syringe plunger 904. In one embodiment, the one or more of the apertures 930 extending through the piston 918 may be positioned within and/or aligned with the plunger stem 920 of the plunger 904 that extends between the thumb tab 922 and the piston 918. The plunger 904 may be a vented plunger.

[0303] In one embodiment, the gas sterilizable syringe 900 may include one or more apertures 932 formed in the distal end wall 910 of the syringe barrel 902.

[0304] In one embodiment, the gas sterilizable syringe 900 may include one or more apertures 934 formed in a wall of the end cap 916, which is securable over the dispensing opening located at the distal end of the dispensing tip 912.

[0305] In one embodiment, the gas sterilizable syringe 900 may include one or more apertures 936 extending through an outer wall of the dispensing tip 912.

[0306] In one embodiment, each of the apertures 926, 930, 932, 934, and 936 formed in the gas sterilizable syringe 900 preferably has a diameter of about 1-5 mm.

[0307] In one embodiment, the apertures 926, 930, 932, 934, and 936 of the gas sterilizable syringe 900 are preferably filled with gas permeable barriers 945 (i.e., gas permeable plugs; gas permeable seals) that enable sterilization gases to pass through the apertures for sterilizing the gas sterilizable syringe 900 while preventing the viscous, flowable material disposed within the fluid chamber 905 of the syringe barrel 902 from passing (e.g., leaking) through the apertures 926, 930, 932, 934, and 936 that have been filled with the gas permeable barriers 945.

[0308] In one embodiment, the formulation used to form the gas permeable barriers is preferably porous, curable, and capable of reliably plugging and/or sealing the apertures while not affecting the stability of the flowable material (e.g., a silicone-based topical skin adhesive) stored within the enclosure (e.g., syringe).

[0309] 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 barriers is introduced into the apertures in an uncured state so that it may conform to the shape of the apertures prior to being cured. After being fully cured, the gas permeable barriers preferably conform to the shapes of the apertures to seal the apertures for enabling sterilization gases to pass therethrough while preventing the flowable material from passing through the gas permeable barriers. In one embodiment, the material (e.g., silicone rubber) used to form the gas permeable barriers preferably bonds to the material used to form the syringe

[0310] Referring to FIG. 11A, in one embodiment, a gas sterilizable syringe 1000 preferably includes a syringe barrel 1002 having an outer wall 1024 that surrounds 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 asymmetric and/or non-uniform shapes. The apertures 1026 may have a diameter of about 1-5 mm.

[0311] Referring to FIG. 11B, in one embodiment, the respective apertures 1026 formed in the outer wall 1024 of the syringe barrel 1002 may be filled with gas permeable barriers 1045 (e.g., plugs) that enable sterilization gases to pass through the apertures 1026 for reaching the viscous, flowable material (not shown) disposed within the fluid chamber 1005, while preventing the viscous, flowable material from leaking and/or escaping through the plugged apertures 1026. In one embodiment, the porous material that fills the apertures 1026 to form the gas permeable barriers 1045 may initially fill the apertures when in an uncured, flowable state, and then be cured to form the gas permeable barriers. In the initial uncured state, the material used to form the gas permeable barriers 1045 preferably conforms to the particular shape of the aperture 1026 associated therewith. After being disposed within the respective apertures 1026 formed in the outer wall 1024 of the syringe barrel 1002, the gas permeable barrier material may be cured for forming structurally stable gas permeable barriers 1045 (e.g., plugs) that fill each of the respective apertures 1026 formed in the outer wall 1024 of the syringe barrel 1002 of the sterilizable syringe 1000. In one embodiment, the gas permeable barriers 1045 may be made of a porous silicone rubber that bonds with the one or more walls of the syringe and/or the syringe barrel 1002.

[0312] In one embodiment, the holes 926, 930, 932, 934 and 936 of the sterilizable syringe 900 shown and described above in FIGS. 10A and 10B may have shapes, configurations and/or diameters that are similar to the shapes, configurations, and/or diameters of the holes 1026 shown in FIGS. 11A and 11B.

[0313] In one embodiment, a sacrificial sleeve may be used for forming and/or shaping the gas permeable barriers that fill the holes formed in a sterilizable syringe. Referring to FIG. 12, in one embodiment, a gas sterilizable syringe 1100 desirably includes a syringe barrel 1102 having an outer wall 1124 that surrounds a fluid chamber 1105, which is 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, prior to filling the apertures 1126 with a material that may be cured to form gas permeable barriers 1145, a sacrificial sleeve 1142 (e.g., a tube-shaped structure) may be inserted into the syringe barrel 1102. An outer surface of the sacrificial sleeve 1142 may engage or be located closely opposite an inner surface 1140 of the outer wall 1124 of the syringe barrel 1102. With the sacrificial sleeve 1142 disposed inside the syringe barrel 1102 for covering the apertures 1126, a flowable, curable, porous material (e.g., silicone) may be disposed within the apertures 1126 to form the gas permeable barriers 1145 that fill the apertures 1126. The uncured material that fills the holes 1126 preferably conforms to the shapes 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 the inside of the outer wall 1124 of the syringe barrel 1102 to provide a smooth interface between the gas permeable barriers 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.

[0314] Referring to FIG. 13, in one embodiment, a gas sterilizable syringe 1200 preferably includes an enclosure 1202 (e.g., a double barrel syringe) having a proximal end 1204 and a distal end 1206. The enclosure 1202 preferably includes a first syringe barrel 1208 that is configured to receive a first part of a flowable material, and a second syringe barrel 1210 that is configured to receive a second part of the flowable material.

[0315] In one embodiment, the enclosure 1202 preferably includes a first dispensing opening 1212 that is in fluid communication with the distal end of the first syringe barrel 1208, and a second dispensing opening 1214 that is in fluid communication with a distal end of the second syringe barrel 1210. In one embodiment, after the first and second parts of the flowable material have been expressed via the respective first and second dispensing openings 1212, 1214, the first and second parts of the flowable material may be mixed together (e.g., with a static mixer) for forming a biocompatible material that is used during a surgical procedure, such as a silicone-based topical skin adhesive.

[0316] In one embodiment, the gas sterilizable syringe 1200 preferably includes a double barrel plunger 1216 including a first plunger 1218 that is configured for being inserted into the open end of the first syringe barrel 1208, and a second plunger 1220 that is configured for being inserted into the open end of the second syringe barrel 1210. In one embodiment, the gas sterilizable syringe 1200 preferably includes a thumb tab 1222 that interconnects proximal ends of the first and second plungers 1218, 1220. The thumb tab 1222 may be engaged for simultaneously depressing the first and second plungers 1218, 1220 in the distal direction DIR1 toward the distal end 1206 of the enclosure 1202, which, in turn, expresses the first and second parts of the flowable material from the respective dispensing openings 1212, 1214.

[0317] In one embodiment, the gas sterilizable syringe 1200 preferably includes an end cap 1224 that is adapted for being secured over the dispensing openings 1212, 1214 located at the distal end 1206 of the enclosure 1202. In one embodiment, the distal end 1206 of the enclosure desirably includes end cap connecting flanges 1255A, 1255B that are configured to engage radially extending projections 1265A 1265B (FIG. 15) provided on an outer surface of a hub of the end cap 1224 for securing 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 therein. With the end cap 1224 secured to the distal end 1206 of the enclosure 1202, the end cap openings 1226, 1228 are preferably adapted to enable sterilization gases to pass through the end cap 1224 and the first and second dispensing openings 1212, 1214 for sterilizing the first and second parts of the flowable material that are disposed within the fluid chambers of the respective first and second syringe barrels 1208, 1210.

[0318] In one embodiment, the gas sterilizable syringe 1200 preferably includes a gas permeable barrier 1230 (e.g., a cured silicone plug) that is configured for being disposed within the end cap 1224 and that is positioned between the distal ends of the first and second dispensing openings 1212, 1214 and an inner surface of the end cap 1224. In one embodiment, the gas permeable barrier may be made of silicone rubber having closed cell porosity.

[0319] In certain embodiments, the gas permeable barrier 1230 may be made of one or more of the following materials: silicone materials including room temperature vulcanized silicone (RTV), liquid silicone rubber (LSR), and high consistency rubber (HCR).

[0320] In one embodiment, the gas permeable barrier 1230 comprises a closed cell structure that has voids and/or porosity. In one embodiment, the gas permeable barrier 1230 may be molded or die cut. In one embodiment, no through holes (i.e., the absence of open cell pores) are present in the gas permeable barrier to seal off the content (e.g., flowable material) of the syringe barrels during repeat vacuum cycles of a gas sterilization process (e.g., an ethylene oxide gas sterilization process).

[0321] In one embodiment, the gas permeable barrier 1230 disposed within the end cap 1224 may be made from a variety of silicone rubber materials having a porosity range of between 1% and 90% of the total volume, and more preferably between 5% and 80% of the total volume, with mainly closed cell porosity.

[0322] In one embodiment, the gas permeable barrier 1230 disposed within the end cap 1224 is made of materials that are compatible with and do not chemically react with the content of the gas sterilizable syringe. Examples of preferred materials for the gas permeable barrier include but are not limited to silicone-polyethylene, silicone-acrylic or silicone-polyurethane copolymers, among others, which may be formed into the shape of the gas permeable barriers disclosed herein

[0323] In one embodiment, the gas permeable barrier 1230 may be made of porous silicone materials having a Shore A hardness scale rating of 5-70.

[0324] In one embodiment, the porosity of a silicone-based polymer used to form the gas permeable barrier 1230 may be generated during curing using an in-situ gas generation method.

[0325] In one embodiment, the gas permeable barrier 1230 may be made using commercially available silicone RTV foams, whereby the formulation may be modified to adjust porosity levels to optimize the results when used with a gas sterilizable syringe.

[0326] In one embodiment the gas permeable barrier 1230 may be molded or die cut. In one embodiment, the gas permeable barrier may be die cut from a larger porous silicone rubber sheet.

[0327] In one embodiment, the gas permeable barrier may be made of other highly gas permeable materials, such a rubbers and/or polymers materials.

[0328] In one embodiment, after the gas permeable barrier 1230 has been assembled with the end cap 1224, the end cap is preferably secured to the distal end of the enclosure 1202. The hub of the end cap preferably forms an air-tight seal with the distal end of the enclosure so that the sterilization gases cannot pass between the lower end of the hub of the end cap and the distal end wall of the enclosure.

[0329] With the end cap 1224 secured to the distal end 1206 of the enclosure 1202, the end cap openings 1226 and 1228 are preferably adapted to enable sterilization gases to pass through the end cap 1224, the gas permeable barrier 1230, and the first and second dispensing openings 1212, 1214 for sterilizing the first and second parts of the flowable material that are disposed within the fluid chambers of the respective first and second syringe barrels 1208, 1210.

[0330] Referring to FIG. 14, in one embodiment, the gas permeable barrier 1230 is preferably porous for enabling sterilization gases to pass through the gas permeable barrier for sterilizing the first and second parts of the flowable material disposed within the enclosure 1202 (FIG. 13) of the gas sterilizable syringe 1200. In one embodiment, the gas permeable barrier 1230 is made of silicone rubber, which contains closed cell pores. In one embodiment, there are no open pores (e.g., micro apertures) present in the gas permeable barrier 1230 in order to prevent leakage of the flowable material disposed within the syringe during the sterilization process. The pores of the gas permeable barrier 1230 are not interconnected to each other to enable the sterilization gases to pass through the gas permeable barrier while blocking the parts of the flowable material from passing therethrough. Thus, the gas permeable barrier 1230 is designed for allowing sterilization gases to flow therethrough while preventing a more viscous liquid from passing and/or flowing therethrough.

[0331] Referring to FIG. 15, in one embodiment, the end cap 1224 may be secured over the dispensing openings 1212, 1214 (FIG. 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 (FIG. 13) desirably includes the end cap connecting flanges 1255A, 1255B that are configured to engage the radially extending projections 12656A 1265B (FIG. 15) provided on an outer surface of the hub of the end cap 1224 for securing 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 air-tight seal with the distal end of the enclosure 1202.

[0332] In one embodiment, the gas permeable barrier 1230 (FIG. 14) is disposed within the end cap 1224 and is in alignment with the first and second end cap openings 1226, 1228 formed in the end cap 1224. The end cap 1224 preferably includes the first end cap opening 1226 and the second end cap opening 1228 that enable sterilization gases to pass through the end cap 1224 and the gas permeable barrier 1230 for sterilizing the parts of the flowable material disposed within the fluid chambers of the respective syringe barrels 1208, 1210.

[0333] In one embodiment, sterilization gases preferably pass through the first and second end cap openings 1226, 1228 and the gas permeable barrier 1230 for entering into the respective fluid chambers of the first and second syringe barrels 1208, 1210.

[0334] In one embodiment, the only entry pathway for the sterilization gases into the fluid chambers of the enclosure is through the first and second end cap openings 1228 formed in the end cap 1224.

[0335] In one embodiment, an end cap for a gas sterilizable syringe may have a single end cap opening.

[0336] In one embodiment, the end cap 1224 for a gas sterilizable syringe may have three or more end cap openings.

[0337] In one embodiment, after the gas sterilizable syringe 1200 has been sterilized, the end cap 1224 preferably remains in place (i.e., secured to the distal end of the enclosure 1202) during shipment and storage of the syringe. During a surgical procedure, the end cap 1224 may be disconnected from the distal end 1206 of the enclosure and replaced by a mixing and dispensing tip or a dispensing tip (not shown) that is securable to the distal end of the enclosure for mixing and/or expressing the flowable material disposed within the first and second syringe barrels 1208, 1210.

[0338] Experiment 1. Gas sterilizable syringes having a structure similar to that shown in FIGS. 13-15, each containing a two-part silicone adhesive formulation, were sterilized using ethylene oxide (EO) gas. Biologic indicators (BI) were placed inside the fluid chambers of the respective syringe barrels of the gas sterilizable syringes to test the functionality of the gas permeable barriers (e.g., gas permeable plugs) and/or the gas permeable plunger seals. The biologic indicators in all of tested devices showed negative results, which indicates that ethylene oxide sterilization gases were able to pass into the syringes and effectively sterilize each of the two-parts of the silicone adhesive formulations disposed within the syringes. The EO exposure time was 785 cycles (about 5 hours) followed by application of a vacuum pressure less than 50 mmHg for removal of residual EO gas in the sterilization chamber. The BI indicated that all the bacteria had been neutralized by the EO cycle, which proved that the syringe is EO permeable. In addition, the residual EO content inside of the sterilized syringes were tested. The result of the testing indicated a residual EO content of 3.59 μg/cm.sup.2, which is well below the required limit of 10 μg/cm.sup.2.

[0339] Referring to FIG. 16A, in one embodiment, the gas sterilizable syringe 1200 preferably includes the enclosure 1202 (e.g., a double barrel syringe) having the first syringe barrel 1208 and the second syringe barrel 1210. The end cap 1224 is preferably secured to the distal end 1206 of the enclosure 1202 for covering the first and second dispensing openings 1212, 1214 (FIG. 13) located at the distal ends of the respective first and second syringe barrels 1208, 1210.

[0340] In one embodiment, the distal ends of the respective first and second plungers 1218, 1220 of the double barrel plunger 1216 are inserted into openings located at the proximal ends of the respective first and second syringe barrels 1208, 1210. The distal end of the first plunger 1218 may include a first plunger seal 1219 that is configured to form a liquid-tight seal with an inner surface of the first syringe barrel 1208 and the distal end of the second plunger 1220 may include a second plunger seal 1221 that is configured to form a liquid-tight seal with an 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, sterilization gases may pass between the outer perimeter of the first plunger seal 1219 and the inner surface of the outer wall of the first syringe barrel 1208, and pass into the first fluid chamber of the first syringe barrel for sterilizing a first part of a flowable composition disposed within the first fluid chamber of the first syringe barrel. In one embodiment, a similar structure is provided for sterilizing the second part of the flowable composition disposed within the second fluid chamber of the second syringe barrel 1210. In one embodiment, sterilization gases may pass between the outer perimeter of the second plunger seal 1221 and the inner surface of the outer wall of the second syringe barrel 1210, and pass into the second fluid chamber of the second syringe barrel for sterilizing a second part of the flowable composition disposed within the second fluid chamber of the second syringe barrel 1210.

[0341] Referring to FIG. 16B, in one embodiment, the first syringe barrel 1208 is preferably filled with a first part of a flowable material and the second syringe barrel 1210 is preferably filled with a second part of a flowable 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 cap 1224 is preferably secured to the distal end 1206 of the enclosure 1202 for covering the dispensing openings 1212, 1214 (FIG. 13) located at the distal ends of the respective first and second syringe barrels 1208, 1210.

[0342] The syringe and the content of the syringe is preferably sterilized by passing sterilization gases through the end cap openings of the end cap 1224. After the syringe 1200 has been sterilized, the end cap 1224 preferably remains in place during shipment and storage of the device. During a surgical procedure, with the syringe located within a sterile environment, the end cap 1224 may be removed and replaced by a mixing and dispensing tip or a dispensing tip that is secured to the distal end 1206 of the enclosure for mixing and/or dispensing the first and second parts of a flowable material that are contained within the respective first and second syringe barrels 1208, 1210.

[0343] Referring to FIG. 17, in one embodiment, a 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 part of a flowable material and a second syringe barrel 1310 having a second fluid compartment configured to receive a second part of a flowable material.

[0344] In one embodiment, the enclosure 1302 preferably includes a first dispensing opening 1312 in fluid communication with the first fluid compartment of the first syringe barrel 1308 and a second dispensing opening 1314 in fluid communication with the second fluid compartment of the second syringe barrel 1310.

[0345] In one embodiment, the gas sterilizable syringe 1300 preferably includes an end cap 1324 including a first end cap opening 1326 and second end cap opening 1328. In one embodiment, the first end cap 1326 is adapted to receive a gas permeable barrier 1330 (e.g., gas permeable plug) that is preferably disposed within the end cap 1324 and that is in alignment 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 secured to the distal end 1306 of the enclosure 1302 for covering 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 enables sterilization gases to pass therethrough for sterilizing the first and second parts of the flowable material that are disposed within the respective first and second syringe barrels 1308, 1310.

[0346] In one embodiment, the gas sterilizable syringe 1300 preferably includes a double barrel plunger 1316 including a first plunger 1318 adapted to be disposed within the first syringe barrel 1308 and second plunger 1320 adapted to be disposed within the second syringe barrel 1310. In one embodiment, the double barrel plunger 1316 preferably includes a thumb tab 1322 secured to proximal ends of the respective first and second plungers 1318, 1320 so that the double barrel plunger 1316 may be simultaneously depressed toward the distal end 1306 of the enclosure 1302.

[0347] In one embodiment, a first gas permeable plunger seal 1362 is preferably securable to a distal end of the first plunger 1318 and a second gas permeable plunger seal 1364 is preferably securable to a distal end of the second plunger 1320. The first and second gas permeable plunger seals 1362, 1364 are preferably configured for enabling sterilization gases to pass therethrough for sterilizing the parts of the flowable material disposed within the respective first and second syringe barrels 1308, 1310. In one embodiment, the first and second gas permeable plunger seals may be made of silicone rubber, which contains closed cell pores. In one embodiment, there are no open pores (e.g., micro apertures) present in the gas permeable plunger seals in order to prevent leakage of the content (e.g., flowable material) disposed within the first and second syringe barrels during a sterilization process.

[0348] In one embodiment, the double barrel plunger 1316 may include vents and/or conduits that enable sterilization gases to pass therethrough for sterilizing 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.

[0349] In one embodiment, the end cap 1324 and the gas permeable barrier 1330 are secured over the distal end 1306 of the enclosure 1302 for covering the openings of the first and second dispensing openings 1312, 1314. With the end cap 1324 and the gas permeable barrier 1330 secured to the distal end of the enclosure 1302, sterilization gases may pass through the first and second end cap openings 1326, 1328, the gas permeable barrier 1330, and the dispensing openings 1312, 1314 for sterilizing the first and second parts of the flowable material disposed within the fluid chambers of the respective first and second syringe barrels 1308, 1310.

[0350] With the first and second plungers 1318, 1320 disposed within the respective first and second syringe barrels 1308, 1310, the sterilization gases may pass through the plungers and/or the first and second gas permeable plunger seals 1362, 1364 for sterilizing the parts of the flowable material disposed within the respective first and second syringe barrels 1308, 1310.

[0351] In one embodiment, the gas sterilizable syringe preferably includes a mixing and dispensing tip 1350 that may be secured to the distal end 1306 of the enclosure 1302. In one embodiment, the mixing and dispensing tip 1350 is preferably configured for mixing together the first and second parts of the flowable composition, and expressing the flowable composition from the distal end of the gas sterilizable syringe 1300.

[0352] In one embodiment, the mixing and dispensing tip 1350 preferably includes a mixing and dispensing tube 1352 having a proximal end 1354 and a distal end 1356. A static mixer 1358 is preferably disposed within the mixing and dispensing tube 1352 for mixing together the first and second parts of the flowable material that is disposed within the respective first and second syringe barrels 1308, 1310.

[0353] In one embodiment, the mixing and dispensing tip 1350 preferably includes a connector 1360 that is adapted for connecting the mixing and dispensing tip 1350 to the distal end 1306 of the enclosure 1302 of the gas sterilizable syringe 1300. In one embodiment, the mixing and dispensing tip 1350 preferably includes one or more radially extending projections 1361 that extend from the outer surface of the connector 1360. In one embodiment, the one or more radially extending projections 1361 are preferably configured to engage securing flanges 1385A, 1385B located at the distal end of the enclosure 1302 for securing the mixing and dispensing tip 1350 to the distal end of the enclosure 1302.

[0354] In one embodiment, during a surgical procedure, the end cap 1324 including the gas permeable barrier 1330 may be disconnected from the distal end 1306 of the enclosure 1302, and replaced by the mixing and dispensing tip 1350. The connector 1360 located at the proximal end of the mixing and dispensing tip 1350 may be secured over the exposed first and second dispensing openings 1312, 1314 located at the distal end 1306 of the enclosure 1302. The one or more radially extending projections 1361 at the proximal end of the connector 1360 preferably engage the securing flanges 1385 at the distal end of the enclosure 1302 for securing the mixing and dispensing tip to the distal end of the enclosure. The thumb tab 1322 secured to the proximal ends of the first and second plungers 1318, 1320 may be depressed in the distal direction DIR1 towards the distal end 1306 of the enclosure 1302 to force the first and second parts of the flowable material to flow out of the first and second dispensing openings 1312, 1314 and into the mixing and dispensing tube 1352 of the mixing and dispensing tip 1350. As the first and second parts of the flowable material flow in a distal direction DIR1 through the mixing and dispensing tube 1352, the two parts of the flowable material are mixed together via the static mixer 1358 that is disposed within the mixing and dispensing tube 1352.

[0355] Referring to FIGS. 18A-18B, 19 and 20, in one embodiment, a 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 dual barrel syringe including a first syringe barrel 1408 having a first fluid compartment 1405A and second syringe barrel 1410 having a second fluid compartment 1405B.

[0356] In one embodiment, the gas sterilizable syringe 1400 preferably includes a dual barrel plunger 1416 including a first plunger 1418 that is adapted to be inserted into a proximal end of the first syringe barrel 1408 and a second plunger 1420 that is adapted to be inserted into a proximal end of the second syringe barrel 1410.

[0357] In one embodiment, the first plunger 1418 preferably includes a first plunger head 1419 located at a distal end thereof and the second plunger 1420 preferably includes a second plunger head 1421 located at a distal end thereof. In one embodiment, the outer perimeters of the first and second plunger heads 1419, 1421 preferably form a liquid-tight seal with inner surfaces of the respective first and second syringe barrels 1408, 1410.

[0358] In one embodiment, the dual barrel plunger 1416 preferably includes a thumb tab 1422 that interconnects proximal ends of the first and second plungers 1418, 1420. In one embodiment, the thumb tab 1422 may be used for depressing the dual barrel plunger 1416 in the distal direction DIR1 (FIGS. 18A and 18B) for expressing first and second parts of a flowable material from the distal ends of the respective first and second syringe barrels 1408, 1410.

[0359] In one embodiment, the gas sterilizable syringe 1400 preferably includes an end cap 1424 secured to the distal end 1406 of the enclosure 1402. A gas permeable barrier 1430 (FIGS. 19 and 20) may be disposed within the end cap 1424 for enabling sterilization gases to pass through the end cap and into the first and second fluid compartments 1405A, 1405B of the respective first and second syringe barrels 1408, 1410 for sterilizing the first and second parts of a flowable material disposed within the enclosure 1402, while preventing the flowable 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 (FIG. 18A) that are configured for enabling the sterilization gases to pass through the end cap 1424 and the gas permeable barrier 1430 (FIGS. 19 and 20) for sterilizing the first and second parts of the flowable material disposed within the first and second fluid chambers 1405A, 1405B of the respective first and second syringe barrels 1408, 1410.

[0360] Referring to FIGS. 19 and 20, in one embodiment, the enclosure 1402 preferably includes a first dispensing opening 1412 in fluid communication with the first fluid compartment 1405A of the first syringe barrel 1408, and a second dispensing opening 1414 in fluid communication with the second fluid compartment 1405B of the second syringe barrel 1410.

[0361] In one embodiment, the first syringe barrel 1408 preferably has an outer wall 1425 having one or more air vent openings 1440 formed therein. The first syringe barrel 1408 preferably includes a first one-way plunger stop 1442 formed on an inner surface of the outer wall 1425 that is located between the one or more air vent openings 1440 and the proximal end 1404 of the enclosure 1402. In one embodiment, after the first plunger head 1419 has moved distally beyond the first one-way plunger stop 1442, the first one-way plunger stop 1442 engages the first plunger to make it easier to move the first plunger 1418 in the distal direction DIR1, and more difficult to retract the first plunger 1418 in the proximal direction DIR2.

[0362] In one embodiment, the first one-way plunger stop 1442 is designed into the inner diameter of the first syringe barrel 1408 such that upon plunger insertion into a filled syringe, the plunger could easily ride over a tapered introduction to the first one-way plunger stop 1442, but once past the first one-way plunger stop 1442, the plunger would butt up against the first one-way plunger stop 1442 and not be able to be retracted without excessive force from this rest position. In one embodiment, the one-way plunger stop 1442 is designed to prevent migration of the first plunger during the pressure changes and vacuum cycles that occur during sterilization.

[0363] In one embodiment, the first syringe barrel 1424 desirably includes elongated rifling 1444 formed in the inner surface of the outer wall 1424 that extends along the length of the first syringe barrel 1408. The elongated rifling 1444 preferably terminates adjacent the one-way plunger stop 1442 of the first syringe barrel 1408. The elongated rifling 1444 preferably guides the sliding movement of the first plunger 1418 relative to the first syringe barrel 1408.

[0364] In one embodiment, the second syringe barrel 1410 preferably includes an outer wall 1427 having one or more air vent holes 1446 formed therein. The second syringe barrel 1410 preferably includes a second one-way plunger stop 1448 that is located between the one or more air vent 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 stop 1448, the second one-way plunger stop 1448 engages the second plunger 1420 for making it easier to move the second plunger 1420 in the distal direction DIR1, while making it more difficult to retract the second plunger 1420 in the proximal direction DIR2. The second syringe barrel 1410 preferably includes elongated rifling 1450 that extends along the length of the second syringe barrel 1410 and that it terminates adjacent the second one-way plunger stop 1448. The elongated rifling 1450 preferably guides the sliding movement of the second plunger 1420 relative to the second syringe barrel 1410.

[0365] In one embodiment, the second one-way plunger stop 1448 is designed into the inner diameter of the second syringe barrel 1410 such that upon plunger insertion into a filled syringe, the plunger could easily ride over a tapered introduction to the second one-way plunger stop 1448, but once past the second one-way plunger stop 1448, the plunger would butt up against the second one-way plunger stop 1448 and not be able to be retracted without excessive force from this rest position. In one embodiment, the second one-way plunger stop 1448 is designed to prevent migration of the second plunger during the pressure changes and vacuum cycles that occur during sterilization.

[0366] In certain embodiments, it may be advantageous to use syringes having a single external dimensional footprint for a product line that provides multiple, different, fill volumes. The shared footprint may be desired to simplify to a single, shared rigid blister packaging for syringes having different fill volumes. The exact location of the one-way plunger stops 1442, 1448 within the syringe barrels may be modified, adjusted, and/or customized so that the one-way plunger stops can be placed inside the syringe barrels at a variety of desired fill volume levels to allow for a single syringe footprint having different fill volumes. For a syringe designed to have a greater fill volume, the one-way plunger stops will be positioned further away from the distal ends of the syringe barrels, and for a syringe designed to have a smaller fill volume, the one-way plunger stops will be positioned closer to the distal ends of the syringe barrel.

[0367] In one embodiment, the gas sterilizable syringe 1400 preferably includes a circumferential flange 1452 located at the proximal end 1404 of the enclosure 1402 and extending around the proximal ends of the respective first and second syringe barrels 1408, 1410. In one embodiment, the circumferential flange 1452 preferably interconnects the proximal ends of the first and second syringe barrels 1408, 1410. A user may engage the circumferential flange with fingers for expressing a flowable material from the distal end of the gas sterilizable syringe.

[0368] 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 radially extending projections 1456A, 1456B provided on an outer surface of the end cap 1424 for releasably securing the end cap 1424 to the distal end 1406 of the enclosure 1402. When secured to the distal end of the enclosure, the end cap preferably forms an air-tight seal with the distal end wall of the enclosure.

[0369] Referring to FIGS. 21A-21B and 22A-22B, in one embodiment, the dual barrel plunger 1416 preferably includes the first plunger 1418 and the second plunger 1420. The thumb tab 1422 interconnects proximal ends of the respective first and second plungers 1418, 1420.

[0370] 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 elongated guide rails 1464 that extend over an outer surface of the first plunger shaft 1458 and along the length of the first plunger shaft. In one embodiment, the elongated guide rails 1464 desirably terminate 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 that are adapted to engage the first one-way plunger stop 1442 of the first syringe barrel 1408 (FIG. 19), for preventing retraction of the first plunger after the one or more radially extending projections 1466 having moved distally beyond the first one-way plunger stop 1442.

[0371] In one embodiment, the first plunger head 1419 is spaced away from the distal end 1462 of the first plunger shaft 1458 to define a first plunger cavity 1468 that is located between the distal end of the first plunger shaft and the first plunger head 1419.

[0372] 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 elongated guide rails 1476 that extend over an outer surface of the second plunger shaft 1470 and along the length of the second plunger shaft. The elongated guide rails 1476 desirably terminate 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 that are adapted to engage the second one-way plunger stop 1448 of the second syringe barrel 1410 (FIG. 19), for preventing retraction of the second plunger after the one or more radially extending projections 1478 have moved distally beyond the second one-way plunger stop 1448.

[0373] In one embodiment, the second plunger head 1421 is spaced away from the distal end 1474 of the second plunger shaft 1470 to define a second plunger cavity 1480 that is located between the distal end of the second plunger shaft 1470 and the second plunger head 1421.

[0374] Referring to FIG. 23, in one embodiment, the dual barrel syringe 1402 is configured to receive the dual barrel plunger 1416 shown and described above in FIGS. 21A-21B and 22A-22B. In one embodiment, the first syringe barrel 1408 is configured to receive the first plunger 1418 (FIGS. 21A and 21B) and the second syringe barrel 1410 is configured to receive the second plunger 1420 (FIGS. 21A and 21B).

[0375] Referring to FIGS. 23 and 24, in one embodiment, the first syringe barrel 1408 preferably includes an outer wall 1425 that extends along the length of the first syringe barrel. The first syringe barrel 1408 preferably includes one or more air vent holes 1440 that pass through the outer wall 1425. The air vent holes 1440 allow ambient air present in the first syringe barrel 1408 to be expressed from the first syringe barrel. The air vent holes 1440 may also provide a supplemental pathway for sterilization gas into the fluid chamber 1405A of the first syringe barrel. The first one-way plunger stop 1442 is preferably formed over the inner surface of the outer wall 1425 of the first syringe barrel 1408. The first one-way plunger stop 142 may be a depression or a projection. The one or more elongated guide slots 1444 (e.g., rifling) are formed in the inner surface of the outer wall 1425 and extend along the length of the first syringe barrel 1408. In one embodiment, the one or more elongated guide slots 1444 are adapted to receive the one or more guide rails 1464 that extend along the length of the first plunger 1418 (FIGS. 21A and 21B).

[0376] Referring to FIG. 23, in one embodiment, the second syringe barrel 1410 preferably includes an outer wall 1427 that extends along the length of the second syringe barrel. The second syringe barrel 1410 preferably includes one or more air vent holes 1446 that pass through the outer wall 1427. The air vent holes 1446 allow ambient air present in the second syringe barrel 1410 to be expressed from the second syringe barrel. The air vent holes 1446 may also provide a supplemental pathway for sterilization gas into the fluid chamber 1405B of the second syringe barrel 1410. The second one-way plunger stop 1448 is preferably formed over the inner surface of the outer wall 1427 of the first syringe barrel 1410. The one or more elongated guide slots 1450 (e.g., rifling) are formed in the inner surface of the outer wall and extend along the length of the second syringe barrel 1410. In one embodiment, the one or more elongated guide slots 1450 are adapted to receive the one or more guide rails 1476 that extend along the length of the second plunger 1420 (FIGS. 21A and 21B) of the dual barrel plunger.

[0377] Referring to FIG. 25, in one embodiment, the first syringe barrel 1408 includes the outer wall 1425 that extends along the length of the first syringe barrel. The one or more elongated guide slots of the first syringe barrel may be evenly spaced from one another over 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-1444D that are formed over the inner surface of the outer wall 1425 of the first syringe barrel 1408. In one embodiment, the four elongated guide slots 1444A-1444D extend along respective axes that are parallel to one another.

[0378] In one embodiment, the second syringe barrel 1410 includes the outer wall 1427 that extends along the length of the first syringe barrel. The one or more elongated guide slots of the second syringe barrel may be evenly spaced from one another over 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-1450D that are formed over the inner surface of the outer wall 1427 of the second syringe barrel 1410. In one embodiment, the four elongated guide slots 1450A-1450D extend along respective axes that are parallel to one another.

[0379] Referring to FIG. 26, in one embodiment, the first plunger 1418 includes the first plunger shaft 1458 that extends along the length of the first plunger. In one embodiment, the one or more elongated guide rails preferably include four elongated guide rails 1464A-1464D that are formed over the outer surface of the first plunger shaft 1458 of the first plunger 1418. In one embodiment, the four elongated guide rails 1464A-1464D are evenly spaced from one another over the outer surface of the first plunger shaft 1458 of the first plunger 1418. In one embodiment, the four elongated guide rails 1464A-1464D extend along respective axes that are parallel to one another.

[0380] In one embodiment, the second plunger 1420 includes the second plunger shaft 1470 that extends along the length of the second plunger. In one embodiment, the one or more elongated guide rails preferably include four elongated guide rails 1476A-1476D that are formed over the outer surface of the second plunger shaft 1470 of the second plunger 1420. In one embodiment, the four elongated guide rails 1476A-1476D are evenly spaced from one another over the outer surface of the second plunger shaft 1470 of the second plunger 1420. In one embodiment, the four elongated guide rails 1476A-1476D extend along respective axes that are parallel to one another.

[0381] Referring to FIG. 27, in one embodiment, when the dual barrel syringe and the 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.

[0382] In one embodiment, the four elongated guide rails 1464A-1464D (FIG. 26) of the first plunger 1418 are seated within the respective four elongated guide slots 1444A-1444D (FIG. 25) of the first syringe barrel 1408 for guiding the sliding movement of the first plunger toward the distal end 1406 of the enclosure 1402.

[0383] In one embodiment, the four elongated guide rails 1476A-1476D (FIG. 26) of the second plunger 1420 are seated within the respective four elongated guide slots 1450A-1450D (FIG. 25) of the second syringe barrel 1410 for guiding the sliding movement of the second plunger toward the distal end 1406 of the enclosure 1402.

[0384] Referring to FIG. 28A, in one embodiment, the dual barrel plunger 1416 (FIG. 21A) is inserted into the dual barrel syringe 1402 so that the first plunger 1418 is disposed within the first syringe barrel 1408 and the second plunger 1420 is disposed within the second syringe barrel 1410. In one embodiment, the first and second plungers 1418, 1420 may be advanced in the distal direction DIR1 to the position shown in FIG. 28A so that the first plunger head 1419 is distal to the one or more vent openings 1440 of the first syringe barrel 1408, the distal end 1462 of the first plunger shaft 1458 is proximal to the one or more air vent openings 1440 of the first syringe barrel 1408, and the first plunger cavity 1468 is aligned with the one or more air vent openings 1440 of the first syringe barrel 1408. The radial projections 1466 located at the distal end 1462 of the first plunger barrel shaft 1458 engage the first one-way plunger stop 1442 of the first syringe barrel for preventing retraction of the first plunger 1418 in the proximal direction DIR2.

[0385] Simultaneously, the second plunger head 1421 is distal to the one or more air vent openings 1446 of the second syringe barrel 1410, the distal end 1474 of the second plunger shaft 1470 is proximal to the one or more air vent openings 1446 of the second syringe barrel 1410, and the second plunger cavity 1480 is aligned with the one or more air vent openings 1446 of the second syringe barrel 1410. The radial projections 1478 located at the distal end 1474 of the second plunger shaft 1470 engage the second one-way plunger stop 1448 of the second syringe barrel 1410 for preventing retraction of the second plunger 1420 in the proximal direction DIR2.

[0386] Referring to FIG. 28B, with the first plunger head 1419 being distal to the one or more air vent openings 1440A, 1440B of the first syringe barrel 1408, the distal end 1462 of the first plunger shaft 1458 is proximal to the air vent openings 1440A, 1440B that extend 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 air vent openings 1440A, 1440B that extend through the outer wall 1425 of the first syringe barrel 1408.

[0387] In one embodiment, a first part of a flowable composition is disposed within the first fluid compartment 1405A of the first syringe barrel 1408. The first plunger head 1419 has an outer perimeter that forms a liquid-tight and/or fluid-tight seal with an inner surface of the outer wall 1425 of the first syringe barrel 1408. Sterilization gases may pass through the air vent openings 1440A, 1440B, flow between the outer perimeter of the first plunger head 1419 and the inner surface of the outer wall 1425 of the first syringe barrel 1408, and pass into the first fluid chamber 1405A for sterilizing the first part of the flowable composition disposed within the first fluid chamber 1405 of the first syringe barrel. A similar structure is provided for sterilizing the flowable composition disposed within the second fluid chamber of the second syringe barrel.

[0388] Referring to FIGS. 29A-29D, in one embodiment, the end cap 1424 is configured for being secured to the distal end of the enclosure 1402 (FIGS. 18A and 18B). The end cap preferably includes first and second end cap openings 1426A, 1426B that enable sterilization gases to pass through the end cap for sterilizing the gas sterilizable syringe 1400 and the first and second parts of the flowable composition disposed within the first and second syringe barrels 1408, 1410 (FIGS. 18A and 18B).

[0389] In one embodiment, the end cap 1424 includes a central hub 1484 with radially extending projections 1456A, 1456B that extend outwardly from the central hub. The end cap 1424 includes an end cap grip 1486 that projects from a distal end of the end cap that may be used for securing the end cap to the distal end of the enclosure 1402 of the gas sterilizable syringe (FIGS. 18a and 18B).

[0390] Referring to FIG. 30, in one embodiment, the end cap 1424 includes the central hub 1484 having a lower end that is open and an upper end that is 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 that is adapted to receive the gas permeable barrier 1430.

[0391] Referring to FIG. 31, in one embodiment, the gas permeable barrier 1430 may be inserted into the end cap chamber 1495, whereupon the end cap openings 1426A, 1426B are preferably in alignment with the gas permeable barrier 1430. In one embodiment, the gas permeable barrier 1430 is preferably positioned adjacent the upper end of the central hub 1484 for being located near a bottom surface of the end cap end wall 1495. The lower end of the central hub 1484 preferably forms an air-tight seal with the distal end wall of the enclosure or syringe so that the sterilization gases may only flow into the gas sterilizable syringe via the first and second end cap openings 1426A, 1426B.

[0392] Referring to FIG. 32, in one embodiment, the end cap 1424 with the gas permeable barrier 1430 disposed therein may be secured to the distal end 1406 of the enclosure 1402 of the 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. The end cap grip 1486 may be used for rotating the end cap 1424 relative to the distal end 1406 of the enclosure 1402 so that the first and second radially extending projections 1566A, 1456B of the end cap engage the end cap securing flanges 1454A, 1454B of the enclosure for securing the end cap 1424 over the first and second dispensing openings 1412, 1414. When secured to the enclosure, the lower end of the hub of the end cap preferably forms an air-tight seal with the distal end of the enclosure.

[0393] In one embodiment, with the end cap 1424 secured to the distal end 1406 of the enclosure 1402, the gas permeable barrier 1430 is disposed between the end cap openings 1426A, 1426B (FIG. 33) and the first and second dispensing openings 1412, 1414 that are in fluid communication with the respective first and second fluid chambers 1405A, 1405B. In one embodiment, the gas sterilizable syringe 1400 may be exposed to sterilization gases, whereupon the sterilization gases pass through the end cap openings 1426A, 1425B, the gas permeable barrier 1430, the first and second dispensing tips 1412, 1414, and into the first and second fluid chambers 1405A, 1405B for sterilizing the interior of the gas sterilizable syringe 1400 and the parts of the flowable material disposed within the first and second fluid chambers.

[0394] In one embodiment, the sterilization gases may also pass through the air vent openings 1440, 1446 of the first and second syringe barrels 1408, 1410 to provide supplemental pathways for sterilizing gases to enter into the first and second fluid chambers 1405A, 1405B of the syringe barrels 1408, 1410 of the gas sterilizable syringe 1400.

[0395] In one embodiment, the gas sterilizable syringe 1400 may be filled with the first and second parts of a flowable material (e.g., a silicon-based topical skin adhesive). In one embodiment, with the end cap 1424 and the gas permeable barrier 1430 secured over the distal end 1406 of the enclosure 1402, the open, proximal ends of the first and second syringe barrels 1408, 1410 are filled with the flowable material. In one embodiment, a first part of the flowable material is disposed within the first fluid chamber 1405A of the first syringe barrel 1408 and a second part of the flowable material is disposed within the second fluid chamber 1405B of the second syringe barrel 1410.

[0396] In one embodiment, the dual barrel plunger 1416 is assembled with the double barrel syringe 1402 so that the first plunger 1418 is disposed within the first fluid chamber 1405A of the first syringe barrel 1408 and the second plunger 1420 is disposed within the second fluid chamber 14058 of the second syringe barrel 1410. The dual barrel plunger 1416 is then advanced in the distal direction DIR1 to exhaust any air that is present within the first and second syringe barrels 1408, 1410 via the air vents openings 1440, 1446 that are formed in the first and second syringe barrels.

[0397] In one embodiment, in the rest position shown in FIG. 32, the radial projections at the distal ends of the plunger shafts preferably engage the one-way plunger stops 1442, 1448 (FIG. 28A) to prevent retraction of the first and second plungers. The plunger cavities 1468, 1480 are desirably in alignment with the respective air vent openings 1440, 1446, whereupon the air vent openings preferably provide a supplemental pathway for sterilization gases to enter into the first and second fluid compartments 1405A, 1405B of the respective first and second syringe barrels 1408, 1410.

[0398] In one embodiment, the sterilization gases preferably pass through the one or more air vent openings 1440 of the first syringe barrel 1408, into the first plunger cavity 1468, and between the outer perimeter of the first plunger head 1419 and the inner surface of the outer wall 1425 of the first syringe barrel for entering into the first fluid chamber 1405A of the first syringe barrel, thereby providing a supplemental path for sterilization gases to flow into the first fluid chamber 1405A.

[0399] In one embodiment, the sterilization gases preferably pass through the one or more air vent openings 1446 of the second syringe barrel 1410, into the second plunger cavity 1480, and between the outer perimeter of the second plunger head 1421 and the inner surface of the outer wall 1427 of the second syringe barrel 1410 for entering into the second fluid chamber 1405B of the second syringe barrel, thereby providing a supplemental path for sterilization gases to flow into the second fluid chamber 1405B.

[0400] Referring to FIG. 33, in one embodiment, a 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 desirably includes a dual barrel plunger 1516 including a first plunger 1518 disposed within the first syringe barrel 1508 and a second plunger 1520 disposed within the second syringe barrel 1510.

[0401] Referring to FIGS. 34A and 34B, in one embodiment, the gas sterilizable syringe 1500 (FIG. 33) desirably includes a multi-function connector 1582 that enables sterilizing, mixing, and dispensing operations to be performed. In one embodiment, the multi-function connector preferably includes a first hub 1583 adapted to be coupled with a distal end of the first syringe barrel 1508 (FIG. 33) and a second hub 1584 adapted to be secured to a distal end of the second syringe barrel 1510 (FIG. 33). The multi-function connector 1582 preferably includes an externally threaded post 1585 that extends distally from the first and second hub 1583, 1584. In one embodiment, a distally extending flange 1586 bisects the externally threaded post 1585 for dividing the externally threaded post 1584 into a first D-shaped opening 1587 and a second D-shaped opening 1588.

[0402] Referring to FIG. 35, in one embodiment, the first D-shaped opening 1587 of the multi-function 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 multi-function 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 shaped of the first D-shaped opening 1587 of the connector 1582, and the second gas permeable barrier 15308 has a D-shape that matches the shape of the second D-shaped opening 1588 of the connector 1582.

[0403] Referring to FIGS. 35 and 36, in one embodiment, after the first and second gas permeable barriers 1530A, 1530B have been inserted into the respective D-shaped openings 1587, 1588 of the multi-function connector 1582, an end cap 1524 having a central opening 1526 is positioned over the gas permeable barriers and the distal end of the externally threaded post 1585. The distally extending flange 1586 of the multi-function connector 1582 bisects the central opening 1526 of the end cap 1524. In one embodiment, the end cap 1524 has internal threads (not shown) that are adapted to mesh with the external threads of the externally threaded post 1585 for securing the end cap 1524 to the externally threaded post 1585.

[0404] Referring to FIGS. 33, 36, and 37, in one embodiment, the multi-function connector 1582 may be assembled with the distal ends of the first and second syringe barrels 1508, 1510 of the 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 multi-function connector 1582, and the distal end of the second syringe barrel 1510 is preferably insertable into the second hub 1584 of the multi-function connector 1582.

[0405] Referring to FIG. 37, in one embodiment, the multi-function connector 1582 preferably includes the first hub 1583 that is configured for being secured to the distal end of the first syringe barrel 1508 (FIG. 33) and the second hub 1584 that is configured for being secured to the distal end of the second syringe barrel 1510 (FIG. 33). The distally extending flange 1586 of the connector 1582 bisects the externally threaded post 1585 for dividing the externally threaded post into a first D-shaped opening 1587 located on one side of the distally extending flange 1586 and the second D-shaped opening 1588 located on the opposite side of the distally extending flange 1586. The gas permeable barriers 1530A, 1530B (FIG. 35) are inserted into the respective D-shaped openings 1587, 1588.

[0406] Referring to FIGS. 35, 36, 38 and 39, in one embodiment, the end cap 1524 may be unthreaded from its connection with the externally threaded post 1585 of the multi-function connector 1582. The first and second gas permeable barriers 1530A, 1530B may be removed from the respective D-shaped openings 1587, 1588 of the externally threaded post 1585. After removing the end cap 1534 and the gas permeable barriers 1530A, 1530B, a mixing and dispensing tip 1550 may be threaded onto the externally threaded post 1585 of the multi-function connector 1582 for expressing the flowable material from the syringe 1500.

[0407] Referring to FIG. 38, in one embodiment, the mixing and dispensing tip 1550 preferably includes one or more radially extending projections 1561 that extend from the outer surface of the connector 1560. The one or more radially extending projections 1561 are preferably adapted to engage securing flanges located at the distal end of an enclosure (e.g., a syringe; a dual barrel syringe) for securing the mixing and dispensing tip 1550 to the distal end of the enclosure.

[0408] Referring to FIGS. 38 and 39, in one embodiment, the mixing and dispensing tip 1550 is preferably configured for mixing together the first and second parts of the flowable composition, and expressing the flowable composition from the distal end of the gas sterilizable syringe 1500.

[0409] In one embodiment, the mixing and dispensing tip 1550 preferably includes 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 for mixing together the first and second parts of the flowable material that is disposed within the respective first and second syringe barrels 1508, 1510. The static mixer 1558 is configured for mixing together the first and second parts of a flowable material as the first and second parts flow along the length of the mixing and dispensing tube 1552.

[0410] In one embodiment, the mixing and dispensing tip 1550 preferably includes a connector 1560 having internal threads (not shown) that are configured to mesh with the external threads of the externally threaded post 1585 (FIG. 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 that may be depressed in the distal direction DIR1 toward the distal end 1506 of the dual barrel syringe 1502 for forcing the content within the first and second syringe barrels 1508, 1510 into the mixing and dispensing tip 1550.

[0411] Referring to FIG. 39, in one embodiment, a flowable material may be dispensed and/or expressed from the mixing and dispensing tip 1550 by depressing the thumb tab 1522 of the dual barrel plunger 1516 in the distal direction designated DIR1 for forcing the two parts of the flowable material to be expressed into the proximal end 1554 of the mixing and dispensing tube 1552. The static mixer 1558 is desirably configured for mixing together the first and second parts of the flowable material as the first and second parts flow along the length of the static mixer 1558 and the mixing and dispensing tube 1552. In one embodiment, during a surgical procedure, the flowable material is preferably expressed from the distal end 1556 of the mixing and dispensing tube 1552.

[0412] Referring to FIG. 40, in one embodiment, the multi-function connector 1582 preferably includes the externally threaded post 1585 (FIG. 35) and the dividing wall 1586 that bisects the externally threaded post 1585 into the first D-shaped opening 1587 and the second D-shaped opening 1588. The first and second hubs 1583, 1584 of the multi-function connector 1582 define a cross-sectional area which is substantially similar to the cross-sectional area of the first and second syringe barrels 1508, 1510 (FIG. 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 multi-function connector 1582.

[0413] FIG. 41 shows a prior art connector 82 having dispensing openings 87, 88 that comprise only 5% of the cross-sectional area defined by the first hub 83 and the second hub 84 of the prior art connector 82.

[0414] The multi-function connector 1582 shown in FIG. 40 provides benefits over the prior art connector 82 shown in FIG. 41. First, the multi-function 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 with the D-shaped openings 1587 and 1588 and the gas permeable stoppers inserted into the D-shaped openings improve sterilization of gas permeable syringes because the syringe's larger outlets allow more sterilizing gas inside the syringe. In addition, the larger size of the D-shaped openings 1587 and 1588 reduces the expression force required to express the flowable composition.

[0415] While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.