Syringe with syringe closure

Abstract

The present invention relates to a syringe comprising a barrel, a plunger, and a vented closure. The barrel has a bore and an end portion having an opening in communication with the bore and a barrel flange disposed outside the opening. The plunger is disposed in the bore and is movable along the bore. The vented closure is attached to the barrel at the end portion, and the vented closure comprises a stopper, a cap, and a filter. The stopper is disposed above and / or in the opening in communication with the bore. The cap comprises a body disposed above the stopper and a fastener engaged with the barrel flange. The filter is disposed between the stopper and the cap or in at least one of the stopper and the cap.

Description

Technical Field

[0001] This disclosure generally relates to closures for syringes. More specifically, this disclosure relates to closures for syringes designed to engage with a pneumatic drive system or actuator and provide a seal over a certain temperature range. Background Technology

[0002] A new class of drugs is attracting widespread attention. These drugs use functional cells to treat diseases. However, these drugs, whether autologous or allogeneic, present certain challenges for therapeutic drug manufacturers or providers.

[0003] Historically, cell-based therapeutics have most commonly been delivered from flexible plastic containers or bags. Because most cell-based therapeutics require cryopreservation at liquid nitrogen temperatures to maintain cell function during transport or patient preparation, bags present several challenges. Bags can be fragile when frozen and are prone to breakage and / or contamination. Additionally, the liquid contained within the bag helps prevent incomplete administration.

[0004] As an alternative, vials have been considered. Vials are generally easy to handle and compatible with cryopreservation. However, vial filling is considered an "open" operation and carries the risk of increased contamination of the pharmaceutical product, especially for small batches of drugs that require manual filling. Therefore, vials are not a complete solution.

[0005] Prefilled syringes are another option, taking the form of ready-to-use delivery containers. However, the design of conventional syringes does not allow them to remain closed during cryogenic storage.

[0006] Preferably, a container is provided that at least partially overcomes the disadvantages of conventional containers for use with cell-based drugs. Summary of the Invention

[0007] In one aspect, a syringe includes a barrel, a plunger, and a vented closure. The barrel has a hole and an end portion having an opening communicating with the hole and a barrel flange disposed outside the opening. The plunger is disposed in the hole and is movable along the hole. The vented closure is attached to the barrel at the end portion and includes a stop, a cap, and a filter. The stop is disposed above and / or in the opening communicating with the hole. The cap includes a body disposed above the stop and a fastener engaging with the barrel flange. The filter is disposed between the stop and the cap, or in at least one of the stop and the cap. Attached Figure Description

[0008] Figure 1This is a partial cross-sectional view of a syringe with a syringe closure according to an embodiment.

[0009] Figure 2 yes Figure 1 An exploded view of a partially enlarged syringe with a syringe closure.

[0010] Figure 3 yes Figure 1 A partially enlarged cross-sectional view of a syringe with a syringe closure.

[0011] Figure 4 yes Figure 1 A partial cross-sectional view of a syringe with a syringe closure and a plunger handle combined.

[0012] Figure 5 yes Figure 1 A schematic diagram of a syringe with a syringe closure combined with a pneumatic drive system or actuator.

[0013] Figure 6A This is a partial cross-sectional view of another embodiment of a syringe used with a syringe closure according to the embodiments disclosed herein.

[0014] Figure 6B Is Figure 6A A three-dimensional view of a collar used in a syringe to form or define a barrel flange.

[0015] Figure 7A This is a partially enlarged cross-sectional view of a syringe with a syringe closure according to another embodiment.

[0016] Figure 7B Is Figure 7A A plan view of the collar used in the implementation method.

[0017] Figure 8A This is a partially enlarged cross-sectional view of a syringe with a syringe closure according to another embodiment, wherein the fastener is disengaged from the barrel flange.

[0018] Figure 8B yes Figure 8A A partially enlarged cross-sectional view of the embodiment, wherein the fasteners engage with the cylinder flange.

[0019] Figure 9A This is a partially enlarged cross-sectional view of a syringe with a syringe closure according to another embodiment, wherein fasteners are fixed to the syringe.

[0020] Figure 9B yes Figure 9A A plan view of the fastener, which is connected to secure the closure to the syringe. Detailed Implementation

[0021] A more detailed description of the systems and methods according to this disclosure is set forth below. It should be understood that the following description of specific apparatuses and methods is intended to be exemplary and not to exhaustively list all possible variations or applications. Therefore, the scope of this disclosure is not intended to be limiting and should be understood to cover variations or implementations that would occur to those skilled in the art.

[0022] Furthermore, while certain relative spatial terms, such as left, right, top, bottom, inside, and outside, have been used relative to the embodiments shown in the accompanying drawings, these terms have been used for ease of interpretation of these particular illustrations. These terms are not intended to require a specific orientation of the syringe and closure during use. If embodiments are illustrated on the page in a different orientation, other relative spatial terms may be used instead of those used in the text, as the reader will recognize.

[0023] From reference Figure 1 Initially, syringe 100 includes a barrel 102, a plunger 104, and a ventilated closure 106. Syringe 100 according to these embodiments can be used to contain, for example, cell-based drugs and can be adapted to store the drug at various temperatures. Furthermore, syringe 100 can provide a container that is a ready-to-use delivery container; pre-filled syringe 100 can be used alone or as part of a self-injector or autoinjector. Additionally, syringe 100 described herein can be used with a pneumatic drive system or actuator to reduce the risk of contamination during filling.

[0024] The syringe 100 has a barrel 102 with a hole 110. The barrel 102 also has a first end 112 having an opening 114 communicating with the hole 110 and a barrel flange 116 disposed outside the opening 114. A plunger 104 is disposed in the hole 110 and is movable along the hole 110, for example, movable along the hole 110 between the first end 112 and a second end 118.

[0025] A ventilation closure 106 is attached to a cylinder 102 at a first end 112 (e.g., via a snap-fit ​​engagement), and the ventilation closure 106 includes a stop 120, a cap 122, and a filter 124. The stop 120 is disposed above and / or within an opening 114 communicating with a bore 110. The cap 122 includes a body 126 disposed above the stop 120 and a fastener 128 engaging with a cylinder flange 116. The filter 124 is disposed between the stop 120 and the cap 122, or within at least one of the stop 120 and the cap 122. Although the cap 122 appears to be spaced apart from the stop 120 by the width of the filter 124, this is an exaggeration for the purpose of illustrating each part—in reality, the cap 122 may abut against both the stop 120 and the filter 124.

[0026] The ventilation closure 106 allows the pneumatic actuator to be attached to the syringe 100 to move the plunger 104 along the orifice 110. See also Figure 5 Because only filtered gas (e.g., air) enters and exits the orifice 110 to move the plunger 104, the potential risk of contamination associated with the use of mechanical actuators (including plunger handles and linear actuators) entering the orifice through the open end is eliminated. Furthermore, the stop 120 provides a further seal useful under cryogenic storage conditions, thereby reducing the role the plunger 104 must play in sealing the orifice 110 under such conditions. Moreover, with the closure 106 capable of being disassembled, the syringe 100 represents an easily constructed, readily available delivery container.

[0027] After a general discussion of syringe 100, details of syringe 100 and some of its uses are discussed.

[0028] As mentioned above Figure 1 The cylinder 102 has a first end 112 and a second end 118. The first end 112 includes an opening 114 and a cylinder flange 116, and the second end 118 is located at the opposite end of the cylinder 102. According to the illustrated embodiment, the cylinder 102 may have a tip 140 at the second end 118, which is in fluid communication with the orifice 110. The tip 140 may be configured to connect with a needle-like element, for example, configured as a Luer lock or Luer slip tip. Alternatively, the tip 140 may include a diaphragm that will be attached to or punctured by a cannula as part of a delivery system; such a diaphragm may be found, for example, in self-injectors or auto-injector devices. The tip 140 may be closed with a cap or lid (not shown) during storage or when not in use.

[0029] According to some embodiments, the tip 140 may be connected to a tube, and the tip 140 defines a processing device that can be used with other devices. In fact, more than one syringe 100 may be attached to such a tube to define the processing device. When the syringe 100 is pre-connected to the tube in such a processing device, the syringe can be terminally sterilized, further reducing the chance of contamination when the cells or other materials being processed are transferred into and out of the syringe 100.

[0030] At the first end 112, the cylindrical flange 116 may hang outward from the cylindrical body 102, but may not hang radially outward from the cylindrical body 102 to the same distance in all directions. For example, see Figure 2 That is, the barrel flange 116 may not form a cantilevered ring hanging from the barrel 102, but may instead take the form of two opposite cantilever structures hanging from opposite sides of the barrel 102 (e.g., left and right sides). These structures can be used during drug delivery from the syringe 100 by resting the index and middle fingers against the flange 116 while pressing the plunger handle attached to the plunger 104. In other variations, the barrel flange 116 may be too narrow to be used in this configuration where the index and middle fingers rest against the flange 116.

[0031] According to other embodiments, the cylindrical flange 116 may not form a single structure with the cylindrical body 102 (i.e., an integral or monolithic structure). Figure 6A and Figure 6B The diagram illustrates such an alternative implementation. For example... Figure 6A As shown, the cylindrical body 102 may have a slight taper between the first end 112 and the second end 118, and an annular structure—referred to herein as a collar 142—may be positioned on the cylindrical body 102 to define the cylindrical body flange 116. See also Figure 6B Specifically, the collar 142 has an opening 144 that connects to a channel 146 formed through the opening 144. As the collar 142 moves along the cylinder 102 from the second end 118 to the first end 112, the cylinder 102 is positioned within the opening 144 and passes through the channel 146. The collar 142 can be held in place at the first end of the cylinder 102 by the taper of the cylinder 102 and by frictional engagement between the collar 142 and the cylinder 102. According to other embodiments, the cylinder 102 may not have a taper, and the collar 142 may be held in place solely by frictional engagement. Still according to other embodiments, the collar 142 can be connected to the cylinder 102 using conventional connection methods.

[0032] Furthermore, while the illustrated embodiment may disclose a single cylindrical flange 116, according to other embodiments, more than one flange may be provided along the cylindrical body 102. For example, a first cylindrical flange integrally formed with the cylindrical body 102 and a second cylindrical flange formed or defined by a collar, such as collar 142, may be present, provided along the cylindrical body 102. The closure 106 may mate with one or more of these cylindrical flanges 116.

[0033] The barrel 102, including the flange 116, can be formed from any of a variety of different plastics. For example, the barrel 102 and the flange 116 can be made from cyclic olefin polymers or copolymers. Such polymers are believed to provide suitable properties over a range of temperatures, including those that the syringe 100 may experience during cryogenic storage. Alternatively, if the flange 116 is not integrally formed with the barrel 102, the two structures can be made from different plastics.

[0034] The design and materials used in the manufacture of plunger 104 can vary. In fact, because the presence of closure 106, and particularly stop 120, is intended to at least partially seal orifice 110, the design and material selection of plunger 104 can be more diverse, since even under cryogenic storage conditions, it is not necessary to design plunger 104 to provide a complete seal. This allows plunger 104 to be designed to optimize (or at least emphasize) other issues, such as deliverability, rather than having to trade performance for storage capacity over a wide temperature range.

[0035] Then return to closure 106 and Figures 1 to 3 The illustrated embodiment of the stop 120 not only covers the opening 114 but also extends into the bore 110 of the cylindrical body 102. Specifically, the stop 120 includes a first end portion 150 disposed within the bore 110 as a plug 152, and a second end portion 154 having a stop flange 156 that hangs from the second end portion 154 outside the bore 110 and above the opening 114. The plug 152 may have a cross-section substantially similar to the cross-section of the bore 110; for example, when the bore 110 is cylindrical, the plug 152 may be cylindrical. Similarly, the stop flange 156 may have a shape complementary to the shape of the cylindrical body flange 116; for example, the stop flange 156 may include a cantilever structure (or wing) hanging from opposite sides (e.g., left and right) of the stop 120. According to other embodiments, the stop 120 may be disposed only above the opening 114 or only within the bore 110.

[0036] The stop 120 remains in place, partly because of the presence of the plug 152 in the hole 110. In fact, the outer surface of the plug 152 facing the inner surface of the hole 110 can have a structure (such as a rib) that mates with the inner surface of the hole 110 to prevent material from passing between the outer surface of the plug 152 and the inner surface of the hole 110 and to improve the retention of the plug 152 in the hole 110. The stop 120 is also held in place by the engagement of the cover 122 with the stop 120, and particularly by the engagement of the cover 122 with the stop flange 156.

[0037] As shown in the figure, the body 126 of the cover 122 covers the stop flange 156. According to some embodiments, the body 126 may be shaped to complement the shape of the stop flange 156, such that the periphery of the body 126 and the stop flange 156 extend together. See also Figure 2 According to other embodiments, the body of the cover 122 may only cover those areas of the stop flange 156 that also cover the cylindrical flange 116. For example, the body of the cover 122 may include a relatively large opening such that the area of ​​the body 126 of the cover 122 covering the flange 156 is connected with a mesh of material, but the cover 122 is still considered to secure the stop flange 156 between the body 126 of the cover 122 and the cylindrical flange 116.

[0038] The cover 122 also includes a fastener 128, and the fastener 128 can take various shapes, as reflected in the alternative embodiments discussed later. Many embodiments of the fastener 128 are configured to directly or indirectly mate or engage with the surface of the cylindrical flange 116 to secure the stop 120 to the cylindrical body 102. That is, the fastener 128 may have features (e.g., barbs) configured to directly abut against the surface of the cylindrical flange 116 to secure the stop 120 to the cylindrical body 102. Alternatively, the fastener 128 may include an intermediate structure (e.g., a collar, similar to the collar 142 described above) configured to directly abut against the surface of the cylindrical flange 116, and then the fastener 128 may include features (e.g., barbs) configured to directly abut against the surface of the intermediate structure (e.g., the collar) to secure the stop 120 to the cylindrical body 102.

[0039] according to Figures 1 to 5 The illustrated implementation method is shown in particular. Figure 2 and Figure 3The fastener 128 includes a skirt 160 that hangs from the body 126—at least those areas covering the cylindrical flange 116—and the skirt 160 has one or more barbs 162 hanging from the skirt. The barbs 162 engage with the cylindrical flange 116 to secure the stop in place and also allow the cover 122 to compress the stop 120 to form a static hermetic seal in the bore 110, which is compatible with room temperature, refrigeration, and cryogenic storage.

[0040] According to the illustrated embodiment, the cover 122 includes a skirt 160 that hangs downward from the body 126. It will be appreciated that directional references are used here for the reader's convenience, so that "downward" does not absolutely limit the nature of the skirt 160. Rather, considering that the cover 122 was previously described as being positioned above a stop flange 156, which in turn covers the cylindrical flange 116, it is intended to express that the skirt 160 hangs from the cover 122 in a direction toward the cylindrical flange 116.

[0041] Although, according to some embodiments, the skirt 160 is not continuous with respect to the periphery of the body 126 of the cover 122, the skirt can be continuous. Instead, the skirt 160 comprises two portions, each of which borders a portion of the body 126 covering the cylindrical flange 116. In other embodiments, the skirt 160 may even be further divided to define multiple skirt portions or fingers. Each of these fingers may have a barb located at its lower end, similar to the barb 162 defined along the periphery of the illustrated skirt portion 160, and each barb engages with the cylindrical flange 116. Such an arrangement provides a more flexible skirt 160 overall, facilitating easier separation of the closure 106 from the cylindrical body 102.

[0042] As described above, the barb 162 engages with the cylindrical flange 116 to secure the closure 106 to the cylindrical body 102. It will be appreciated that the barb 162 may have a head 164 with an inner surface 166, and the cylindrical flange 116 may have an outer surface 168. See also Figure 3 Where spatial orientation is used elsewhere for ease of explanation, surface 166 may be referred to as facing upwards, and surface 168 may be referred to as facing downwards. As shown, with the stop 120 and cover 122 arranged on the cylinder 102, surfaces 166 and 168 abut against each other.

[0043] According to embodiments such as those illustrated, the engagement of surfaces 166, 168 is the primary attachment mechanism between the cylinder 102 and the snap-fit ​​closure 106, allowing the closure 106 to be separated from the cylinder 102 under sufficient force. Even if the applied force permanently deforms or even fails the cover 122 (particularly the skirt 160), the closure 106 can still be described as removable. In fact, according to some embodiments, the skirt 160 and / or the barbs 162 can be separated from the cover 122 to allow the closure 106 to be detached from the cylinder 102. According to such embodiments, a fracturing boundary (e.g., a weak point line in the material) can be formed between the skirt 160 and / or the barbs 162 and the remainder of the cover 122, allowing the skirt and / or the barbs 162 to separate from the remainder of the cover 122, wherein material peels or tears along the fracturing boundary. The skirt 160 and / or the barbs 162 can also be removable after separation. On the other hand, if the force required to separate the cover 122 causes the cover 122—particularly the skirt 160—to deflect or bend, but not to cause permanent deformation or failure, then the closure 106 can be described as reversibly detachable.

[0044] The closure 106 can be detachable so that, after filling, the mechanical control mechanism can directly engage with the plunger 104. That is, the closure 106 is designed to allow gas (e.g., air) to move the plunger 104 along the orifice 110. However, while a pneumatic system can be used to move the plunger 104 during filling, many delivery systems use mechanical control mechanisms rather than pneumatic ones. For example, as... Figure 4 As shown, the closure 106 can be disassembled, allowing the first end 180 of the plunger handle 182 to be positioned through the opening 114 and into the bore 110. The plunger 104 may have an attachment mechanism 184 formed in or on the surface of the plunger 104 that engages with the plunger handle 182—for example, the first end 180. According to an embodiment, the first end 180 may have threads formed on it, and the plunger 104 may have a threaded hole formed in it, allowing the first end 180 to be attached to the plunger 104 by screwing it into the threaded hole 184.

[0045] As generally mentioned above, the closure 106 is ventilated, allowing the syringe 100 to be used with a pneumatic actuator during filling, and perhaps also as part of a delivery system along with the gas actuator. For this purpose, according to the illustrated embodiment, the bodies 126 of the stop 120 and the cap 122 each have at least one through cavity 190, 192. See also Figure 1 and Figure 3As also shown in the figure, the through cavities 190 and 192 of the stop 120 and the cap 122 are aligned along a common longitudinal axis 194, which is also the central axis of the syringe 100. The filter 124 is disposed along axis 194 between the body 126 of the cap 122 and the stop 120, and therefore between the through cavity 190 of the stop 120 and the through cavity 192 of the cap 122. The filter 124 can be made of a filter medium capable of filtering particles as small as 0.22 micrometers.

[0046] In addition to capturing the filter 124 between the stop 120 and the cover 122, the filter 124 can be attached either to the stop 120 or to the cover 122. For example, the filter 124 can be irreversibly attached to either the stop 120 or the cover 122 using adhesives or common plastic bonding techniques. These techniques may include, for example, spin welding, hot plate welding, radio frequency (RF) welding, and laser welding, and can be selected based on the materials used for the stop 120 or the cover 122 and the filter 124.

[0047] According to other embodiments, the filter 124 may be embedded in the stop portion 120 or the cover 122. According to such an embodiment, the filter 124 may, for example, be located in one of the through cavities 190, 192, but still at the junction between the through cavities 190, 192. Also according to other embodiments, the filter 124 may not be located between the through cavities 190, 192, but rather at the inner end of the through cavity 190 or the outer end of the through cavity 192. Further alternative arrangements are also possible.

[0048] As described above, the closure 106 can be used with a pneumatic actuator. The closure 106 can be connected to a pneumatic actuator, such as... Figure 5 The actuator 200 is shown in the diagram. It will be appreciated that the pneumatic actuator 200 can be, for example, in the form of a pneumatic pump and can be connected to the injector 100 with pressure, vacuum, or ventilation. Alternatively, the pneumatic actuator may include a combination of a valve and a pressurization reservoir.

[0049] What will be recognized is that, although it has already been Figures 1 to 5 The illustration shows one embodiment of the syringe 100 with a closure 106, but other embodiments are also possible, such as... Figures 7A to 7B , Figures 8A to 8B , Figures 9A to 9B As illustrated in the figure. The features of syringe 100 use the same numbering scheme, but it should be noted that the above discussion of variations of syringe 100 (e.g., refer to...) Figures 6A-6BThe same applies to these other embodiments. For ease of reading, the following numbering scheme has been adopted, wherein those structures similar to those of closure 106 are... Figures 7A to 7B , Figures 8A to 8B , Figures 9A to 9B The structures of the closures have been numbered in a similar but not identical manner.

[0050] Figure 7A and Figure 7B A ventilation closure 206 is shown attached to the barrel 102 of the syringe 100 at its first end 112. The ventilation closure 206 includes a stop 120, a cap 222, and a filter 224. Figures 1 to 5 Similar to the previous implementation, the stop portion 120 is disposed above and within the opening 114 communicating with the hole 110. The cover 222 includes a body 226 disposed above the stop portion 120 and a fastener 228 engaging with the cylinder flange 116. The filter 224 is illustrated as being disposed between the stop portion 120 and the cover 222.

[0051] Figure 7A and Figure 7B The implementation method of cover 222 and Figures 1 to 5 The difference in the implementation of the cover 122 is that the fastener 228 does not directly engage with the cylindrical flange 116. Instead, the cover 222 engages with an intermediate structure disposed between the cover 222 and the cylindrical flange 116, wherein the surface of the cover 222 abuts (i.e., in direct contact) with the surface of the intermediate structure, and the surface of the intermediate structure abuts with the surface of the cylindrical flange 116.

[0052] The cap 222 includes a skirt 260 with a plurality of spaced barbs 262, each of the barbs 262 being individually supported around the periphery of the cap 222. Each of the barbs 262 has a head 264 with an inner surface 266 that functions similarly to the surface 166 of the barbs 162 of the cap 122. The closure 206 also includes the aforementioned intermediate structure or collar 268, which mates with the cap 222, particularly the barbs 262, to secure the cap 222 to the barrel 102 of the syringe 100.

[0053] The collar 268 has a channel 270 through which the barrel 102 of the syringe 100 is received when the collar 268 is disposed on the barrel 102. Similar to the collar 142, the barrel 102 can be disposed within the channel 270 when the collar 268 moves from the second end 118 to the first end 112. The movement of the collar 268 can be stopped at the first end 112 by the barrel flange 116 when the surface of the collar 268 abuts against the barrel flange 116. According to the illustrated embodiment, the collar 268 may have a recess 272 formed on the upper surface of the collar 268 to receive the barrel flange when the upper surface of the collar 268 abuts against the barrel flange 116.

[0054] The collar 268 also has an edge 274 extending radially outward from the channel 270 and the recess 272. The edge 274 has a plurality of apertures 276 arranged around its periphery. As shown, there are six apertures 276, although in other embodiments, there may be more or fewer apertures 276. The apertures 276 are spaced apart from each other in a mirror-image configuration about at least one axis, although again, this is not required in all embodiments.

[0055] The orifice 276 is formed such that the barb 262 is received through the collar 268 and abuts against the outer surface 278 of the collar 268 to secure the cover 222 to the cylindrical flange 116. Specifically, the surface of the recess 272 abuts against the cylindrical flange 116, and the opposing surfaces 266 and 278 of the barb 262 and the collar 268 also abut. In this way, the closure 206 is indirectly secured to the cylindrical flange 116.

[0056] In use, the collar 268 can initially be positioned on the cylinder 102, with the collar 268 advancing from the second end 118 to the first end 112 until the cylinder flange 116 abuts against the collar 268 and is received within the recess 272. At this point, the filter 224 can be positioned between the stop 120 and the cover 222, with the cover 222 pressed downward against the collar 268. As the barb 262 moves through the orifice 276, the barb 262 can deflect outward until the head 264 of the barb 262 exceeds the outer surface 278 of the collar 268. At this point, the barb 262 moves inward, and surfaces 266 and 278 abut to hold the cover 222 against the collar 268, with the cylinder flange 116, the stop 120, and the filter 224 positioned between the cover 222 and the collar 268.

[0057] Figure 8A and Figure 8B The illustration shows a ventilation closure 306, which serves as the first end 112 attached to the barrel 102 of the syringe 100. The ventilation closure 306 includes a stop 120, a cap 322, and a filter 324. Figures 1 to 5Similar to the previous implementation, the stop portion 120 is disposed above and within the opening 114 communicating with the hole 110. The cover 322 includes a body 326 disposed above the stop portion 120 and a fastener 328 engaging with the cylinder flange 116. The filter 324 is illustrated as being disposed between the stop portion 120 and the cover 322.

[0058] Figure 8A and Figure 8B Implementation methods and Figure 7A and Figure 7B The similarity of the implementation lies in that the skirt 360 has a plurality of spaced barbs 362, each barb 362 being supported around the periphery of the cover 322. Each barb 362 has a head 364 with an inner surface 366, the head 364 functioning similarly to the barb in the above-described embodiment. In the illustrated embodiment, surface 366 abuts against surface 368 of the cylindrical flange 116; in another embodiment, it can be like... Figure 7A and Figure 7B In the embodiment, a collar is used, and surface 366 can abut against the surface of the collar, while the collar itself contacts the cylinder flange 116.

[0059] A significant difference from the aforementioned embodiments is that the fastener 328 (particularly the barb 362) is connected to the body 326 of the cap 322 via a hinge 370. As shown, the hinge 370 is a movable hinge made of the material forming the body 326 and the skirt 360 of the cap 322. According to other embodiments, the hinge 370 may be a separate structure for at least one of the body 326 and the skirt 360, and the hinge 370 is connected to the body 326 and / or the skirt 360. The hinge 370 allows the fastener 328 to be spaced a certain distance from the syringe 100 during attachment of the closure 306 to the syringe 100.

[0060] In use, the filter 324 is disposed on the stop 120, or, according to some embodiments, the filter 324 is connected to the stop 120. Then, a cover 322 is disposed above the stop 120 and the filter 324, as shown. Figure 8A As shown in the diagram. Then, fastener 328 can be... Figure 8A The first position or state shown is brought in Figure 8B The second position or state is shown. As shown, in the first position, the barb 362 is radially outwardly spaced from the body 326 of the cap 322, thereby limiting interference between the barb 362 and the barrel flange 116 (or collar, in those embodiments including the collar) when the cap 322 is fitted onto the syringe. In the second position, the barb 362 is brought into the second position, wherein surfaces 366, 368 abut to secure the cap 322 (and closure 306) to the syringe 100.

[0061] Figure 9A and Figure 9B A ventilated closure 406 is shown attached to the barrel 102 of the syringe 100 at a first end 112. The ventilated closure 406 includes a stop 120, a cap 422, and a filter 424. As in the previous embodiment, the stop 120 is disposed above and within an opening 114 communicating with the hole 110. The cap 422 includes a body 426 disposed above the stop 120. Unlike the previous embodiment, the cap 422 has a fastener 428, which is a separate structure from the body 426 of the cap 422.

[0062] like Figure 9A As shown in the cross-section, the fastener 428 takes the form of a C-shaped clamp 460. It can be assumed that the clamp 460 performs the functions of the skirt and barbs in the previous embodiments. The clamp 460 includes an upper portion 462, a lower portion 464, and a bridging portion 466 connecting the upper portion 462 to the lower portion 464.

[0063] like Figure 9A The installed upper portion 462 has its inner surface 468 abutting against the outer surface 470 of the body 426 of the cap 422. Similarly, the inner surface 472 of the lower portion 464 abuts against the outer surface 474 of the barrel flange 116. Thus, the body 426 of the cap 422, the filter 424, the stop flange 156, and the barrel flange 116 are positioned between the opposing inner surfaces 468 and 472 of the clamping member 460 to secure the closure 406 to the syringe 100 and to hold each component in place.

[0064] According to the illustrated embodiment, the clamping member 460 has two paired halves 476, 478 (according to...) Figure 9B The orientation of the clamping member 460 (which may be referred to as the left half 476 and the right half 478) is such that halves 476 and 478 are connected to each other to hold the clamping member 460 in place on the syringe 100. For this purpose, one or more connectors may be provided on the left half 476 or the right half 478 of the clamping member 460, or mating portions of the connectors may be provided on the left half 476 or the right half 478. The connectors hold the halves 476 and 478 of the clamping member 460 together to ensure that the closure 406 remains fixed to the syringe 100.

[0065] like Figure 9B As shown, the upper portion 462 has two connectors 480, 482 disposed on opposite sides of the clamping member 460 (or opposite sides of the syringe 100). The lower portion 464 may also have connectors (not shown) disposed on opposite sides of the clamping member 460. Although one arrangement has been illustrated, this is not the only possible configuration of the connectors.

[0066] As in Figure 9A As best seen in the diagram, each connector (e.g., connector 480) may include a barb 484 and a recess 486. As shown, the barb 484 may be part of (attached to or integral with) the right half 478, while the recess 486 may be formed in the left half 476. This is an example of an embodiment of the connector where the mating portion of the connector may be located either on the left half 476 or on the right half 478. The barb 484 may be received in the recess 486 such that the complementary structures of the barb 484 and the recess 486 match to prevent the barb 484 from disengaging from or separating from the recess 486 without applying a specific amount of force. The amount of force may be selected based on the normal operating conditions of the closure and whether the fastener 428 is designed to be reversibly or irreversibly disassembled.

[0067] The connector can be configured such that one half (e.g., right half 478) has only barbs 484, while the other half (e.g., left half 476) has only recesses configured to receive the barbs 484. Alternatively, the connector of the upper half 462 may have barbs 484 on the right half 478 and recesses on the left half 476, while the connector of the lower half 464 may have barbs on the left half 476 and recesses 486 on the right half 478. As yet another alternative, connector 480 may have barbs 484 on the right half 478 and recesses 486 on the left half 476, while connector 482 may have barbs 484 on the left half 476 and recesses 486 on the right half 478. According to such embodiments, the connector on the lower half 464 may be the same as its counterpart on the upper half 462, or may be reversed.

[0068] It will also be recognized that, although we have mentioned that fastener 428 (particularly clamping member 460) has a left half 476 and a right half 478, this is done for ease of explanation. Clamping member 460 may have two relatively equal parts that are joined together to form clamping member 460, but it is not required that each part is exactly or approximately 50% of the entire structure. Furthermore, although clamping member 460 has been illustrated as being arranged around the entire periphery of cylindrical flange 116 and stop flange 156, this need not be the case for every instance of this embodiment of closure member 406.

[0069] In use, the filter 424 can be positioned above the stop 120, and the body 426 is positioned above both the filter 424 and the stop 120. As the halves 476 and 478 advance from opposite sides of the syringe 100 toward the syringe 100, a downward force can be applied to the body 426, thereby applying force to the filter 424 and the stop 120. The inner surface 468 of the upper portion 462 of the clamp faces the outer surface 470 of the body 426, and may even abut against the outer surface 470 of the body 426, while the inner surface 472 faces the outer surface 474 of the barrel flange 116, and may even abut against the outer surface 474 of the barrel flange 116. The halves 476 and 478 advance toward each other until the barb 484 advances in the direction of the recess 486 until the barb 484 and the recess 486 mate, connecting the two halves 476 and 478 of the clamp 460 together. In this position or state, the body 426, filter 424, stop 120, and cylinder flange 116 are disposed between the opposing surfaces 468 and 472 of the clamping member 460.

[0070] It may also have similar characteristics Figure 9A and Figure 9B In another embodiment of the implementation, the body 426 of the cover 422 is integrated into the upper portion 462 of the clamping member 460. For example, when the filter 424 is connected to the stop 120 or the filter 424 is embedded in the stop 120, the body 426 can be integrated into the upper portion 462. In this case, the opening at the center of the upper portion 462 can be larger than... Figure 9A and Figure 9B The size shown is smaller because when pushing the halves 476 and 478 toward each other, it is not necessary to apply force to the individual elements of the cover 422.

[0071] The syringe with a syringe closure according to the disclosed embodiment offers certain advantages over conventional syringes used with pneumatic pumps. As mentioned above, the closure allows for the use of a pneumatic actuator during filling, and it limits or eliminates potential sources of contamination because air can be easily filtered. Furthermore, the closure allows the syringe to be stored over a wide temperature range while reducing the design burden on the plunger (especially the plunger stop) to provide the seal required during cryogenic storage. Syringes incorporating such a closure can provide a delivery container that is readily available and easily integrated directly into instruments. The rigidity of the container can also allow robotic instruments to facilitate connectivity for large-scale operations.

[0072] Therefore, an improved syringe, together with an improved syringe closure, has been disclosed. The description provided above and the other aspects provided below are for illustrative purposes and are not intended to limit the scope of the disclosure to any particular method, system, device, or apparatus described herein.

[0073] Other aspects

[0074] Aspect 1. A syringe, comprising:

[0075] A cylindrical body having a hole, an opening communicating with the hole at one end of the cylindrical body, and a cylindrical body flange disposed outside the opening;

[0076] A plunger disposed in the bore and movable along the bore; and

[0077] A ventilation closure, attached to the cylinder at its end, includes a stop, a cover, and a filter.

[0078] The stop portion is disposed above the opening communicating with the hole and / or in the opening communicating with the hole.

[0079] The cover has a body disposed above the stop portion and fasteners that engage with the flange of the cylinder.

[0080] The filter is disposed between the stop and the cover, or in at least one of the stop and the cover.

[0081] Aspect 2. The syringe according to aspect 1, wherein the barrel flange includes a collar disposed on the barrel at an end of the barrel flange.

[0082] Aspect 3. The syringe according to aspect 1 or 2, wherein the stop portion includes an elastic stop portion having a plug disposed within the hole and a stop portion flange hanging from an end of the stop portion outside the hole.

[0083] Aspect 4. The syringe according to aspect 3, wherein the cap secures the stop flange between the body of the cap and the barrel flange.

[0084] Aspect 5. The syringe according to any one of Aspects 1 to 4, wherein the fastener includes a downwardly hanging skirt having barbs that engage with the barrel flange.

[0085] Aspect 6. The syringe according to aspect 5, wherein the barb has abutting against a surface of the barrel flange to engage the surface of the barrel flange.

[0086] Aspect 7. The syringe according to aspect 5, wherein the closure includes a collar abutting against the barrel flange, and the barb abuts against the surface of the collar to engage the barrel flange.

[0087] Aspect 8. The syringe according to any one of Aspects 5 to 7, wherein the fastener is attached to the body of the cap via a hinge.

[0088] Aspect 9. The syringe according to any one of Aspects 1 to 4, wherein the fastener includes a clamping member having opposing inner surfaces, at least a portion of the stop and the barrel flange being disposed between the opposing inner surfaces of the clamping member.

[0089] Aspect 10. The syringe according to aspect 9, wherein the clamping member is disposed around the periphery of the syringe and is divided into at least two portions, the at least two portions being connected to at least a portion of the stop portion disposed between opposing inner surfaces of the clamping member and the cylindrical flange.

[0090] Aspect 11. The syringe according to aspect 9 or 10, wherein the body of the cap is separated from the clamping member, and the body of the cap, at least a portion of the stop portion and the barrel flange are disposed between the opposing inner surfaces of the clamping member.

[0091] Aspect 12. The syringe according to any one of Aspects 1 to 11, wherein the cap is configured to compress the stop to form an airtight seal in the orifice.

[0092] Aspect 13. The syringe according to any one of Aspects 1 to 12, wherein both the stop portion and the body of the cap have a through cavity, and the filter is disposed between the through cavity of the stop portion and the through cavity of the cap.

[0093] Aspect 14. The syringe according to aspect 13, wherein the through cavity of the stop and the through cavity of the cap are aligned along a common longitudinal axis.

[0094] Aspect 15. The syringe according to any one of aspects 1 to 14, wherein the closure is detachably attached to the barrel.

[0095] Aspect 16. The syringe according to aspect 15 further includes a plunger handle configured to pass through the opening and enter the orifice, the plunger handle being attachable to the plunger to control the movement of the plunger along the orifice.

[0096] Aspect 17. The syringe according to any one of Aspects 1 to 16, wherein the filter comprises a 0.22-micron filter medium.

[0097] Aspect 18. The syringe according to any one of Aspects 1 to 17, wherein the barrel comprises a cyclic olefin copolymer.

[0098] Aspect 19. The syringe according to any one of Aspects 1 to 18, wherein the barrel has a second end opposite to the said end, the plunger is movable along the orifice between the said end and the second end, the second end including a tip in fluid communication with the orifice.

[0099] Aspect 20. A processing apparatus comprising a tube and at least one syringe according to aspect 19, wherein the tip of at least one of the syringes is connected to the tube.

[0100] Aspect 21. A processing system comprising a pneumatic actuator connected to the closure of the syringe according to any one of aspects 1 to 19.

Claims

1. A syringe comprising: a barrel having a bore, an end of the barrel having an opening in communication with the bore and a barrel flange disposed outside the opening; a plunger disposed in the bore, the plunger being movable along the bore; and a vent closure attached to the barrel at the end, the vent closure comprising a stopper, a cap, and a filter, the stopper having a first end comprising a plug disposed within the bore and a second end disposed above the opening, the stopper further comprising a stopper flange depending from the second end of the stopper outside the bore and abutting a first surface of the barrel flange, the cap having a body disposed above the stopper and a fastener engaging the barrel flange, wherein the cap secures the stopper flange between the body of the cap and the barrel flange, the filter disposed between the stopper and the cap or in at least one of the stopper and the cap, wherein the fastener of the cap has a skirt having at least two spaced apart portions depending downwardly from the body of the cap, the portions snap-fit engaging a second surface of the barrel flange opposite the first surface. the barrel flange comprises a collar disposed on the barrel at an end of the barrel flange.

2. The syringe of claim 1, wherein, the stopper comprises an elastomeric stopper having a plug disposed within the bore and a stopper flange depending from an end of the stopper outside the bore.

3. The syringe of claim 1 or 2, wherein, the vent closure comprises the skirt depending downwardly and having barbs engaging the barrel flange against the collar.

4. The syringe of claim 3, wherein, the fastener is attached to the body of the cap by a hinge.

5. The syringe of claim 4, wherein, the fastener comprises a clamp having opposing inner surfaces, and at least a portion of the stopper and the barrel flange are disposed between the opposing inner surfaces of the clamp, and the clamp is disposed about a circumference of the syringe and is divided into at least two portions connected with the at least a portion of the stopper and the barrel flange disposed between the opposing inner surfaces of the clamp.

6. The syringe of claim 1, wherein, the body of the cap is separate from the clamp, and the body of the cap, the at least a portion of the stopper, and the barrel flange are disposed between the opposing inner surfaces of the clamp.

7. The syringe of claim 6, wherein, the cap is configured to compress the stopper to form an air-tight seal in the bore.

8. The syringe of claim 1, wherein, the stopper and the body of the cap each have a through cavity, and the filter is disposed between the through cavity of the stopper and the through cavity of the cap.

9. The syringe of claim 1, wherein, 10. The syringe of claim 1, further comprising a plunger handle disposed through the opening and into the bore, the plunger handle being attachable to the plunger to control movement of the plunger along the bore. the filter comprises a 0.22 micron filter media.

11. The syringe of claim 1, wherein, the barrel comprises cyclic olefin copolymer.

12. The syringe of claim 1, wherein, the barrel flange comprises a collar disposed on the barrel at an end of the barrel flange.

13. The syringe of claim 1, wherein, The barrel has an opposite end opposite the end, the plunger being movable along the bore between the end and the opposite end, the opposite end including a tip in fluid communication with the bore.

14. A treatment device comprising a tube and at least one syringe according to claim 13, wherein the tip of at least one of the syringes is connected to the tube.

15. A handling system comprising a pneumatic driver and a syringe according to claim 1, wherein, The pneumatic driver is connected with the vent closure of the syringe.

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