Crimping and fluidly connecting cap and system

Abstract

A cap for crimping a stopper on a syringe and for fluidly connecting the syringe to an adapter is described. The cap includes a connector that connects to the syringe. The cap includes a spike movably disposed within the interior of the connector between a first position and a second position. The spike can abut against the adapter to fluidly connect to the adapter. When the connector is connected to the syringe and the spike is in the first position, a tip of the spike is spaced from an inner surface of the stopper. When the connector is connected to the syringe and the spike is in the second position, the tip of the spike extends through the stopper to fluidly connect the spike and an interior of the syringe.

Description

Atty Docket No.202300081-WO CRIMPING AND FLUIDLY CONNECTING CAP AND SYSTEM CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 535,529, filed August 30, 2023, the entirety of which is incorporated herein for any and all purposes. FIELD OF THE INVENTION

[0002] The present disclosure generally relates to primary container systems and methods, and more particularly, to caps and systems for crimping and fluidly connecting such as for crimping a stopper on a syringe and for selectively fluidly connecting the syringe to an adapter. BACKGROUND

[0003] Bioprinting is an extended application of additive manufacturing where bioinks are deposited, layer-by-layer, for fabrication of functional tissues and organs. Bioprinting can be used for regenerative medicine to, for example, address organ shortage challenges, for pharmaceutical testing, for food production, among other possibilities.

[0004] The landscape of injectable medicaments is evolving. For example, monoclonal antibodies, lipid nanoparticles, gene therapy modalities, and cell therapies can each involve the injection of medicaments in this evolving landscape. Some injectable medicaments have high viscosities and / or need to be injected in precise amounts.

[0005] Various techniques exist for the deposition of bioinks and / or injection of medicaments. Such techniques including pneumatics, ink-jet printing, extrusion printing, stereolithography, laser assisted bioprinting techniques, among others. For example, pneumatic drivers with compressed air at pressures ranging from 10-200 kPa can be used for pneumatic extrusion bioprinters.

[0006] For at least some techniques for the deposition of bioinks and for injection of some medicaments, fluid communication between a pressure source and the interior of a syringe moves a piston and selectively ejects a substance (e.g., a bioink, a medicament,Atty Docket No.202300081-WO among other possibilities) from the syringe. This fluid communication is commonly achieved by manually piercing the stopper with a hollow spike that is fluidly connected to the pressure source. SUMMARY

[0007] The inventors recognized that existing techniques for fluidly connecting syringes or other primary containers to pneumatics or other drivers can introduce risk to the operator of the bioprinter or injection device. For example, manually piercing the stopper with a hollow spike that is fluidly connected to the pressure source can present a risk of inadvertent needle sticks. Manual piercing is also a cumbersome technique.

[0008] Therefore, there exists a need for a cap or system that is compatible with containers used for bioprinting and / or medicament injection and that can selectively fluidly connect the container with a pressure source for controlling the bioprinting or medicament injection. The inventors also recognized it would be beneficial for the cap or system to also serve as a crimp to hold a stopper in place on the container and seal the container. This can improve the seal of the container and allow the container to be used in applications with sealing challenges (e.g., maintenance of sterility and / or pH at different storage conditions), such as for bioinks or medicaments that are stored at cryotemperatures.

[0009] The foregoing needs are met by a cap for crimping a stopper on a syringe and for fluidly connecting the syringe to an adapter. The cap includes a connector configured to connect to the syringe to crimp the stopper on the syringe. The connector defines an interior. The cap also includes a spike that extends along a longitudinal axis of the cap. The spike is movably disposed along the longitudinal axis within the interior of the connector between a first position and a second position. The spike is hollow and may include a tip and a collar spaced from the tip. The collar is configured to abut against the adapter to fluidly connect the adapter and the spike. When the connector is connected to the syringe and the spike is in the first position, the tip of the spike is spaced from an inner surface of the stopper. When the connector is connected to the syringe and the spike is in the second position, the tip of the spike extends through the stopper to fluidly connect the spike and the syringe.Atty Docket No.202300081-WO

[0010] Implementations may include one or more of the following features. The connector may include arms that are deflectable. The arms are configured to hold the spike in the first position, and when a force is applied to the spike, the arms are configured to deflect to permit movement of the spike from the first position to the second position. The arms may include protrusions that project inwardly into the interior defined by the connector. At least one of the protrusions is configured to hold the spike in the first position. The at least one of the protrusions is configured to hold the spike in the second position after the force is applied to the spike to move the spike from the first position to the second position. The collar defines an interior that is configured to receive the adapter. The collar may include a surface that is configured to abut against a surface of the adapter. The tip and the collar are integral. The spike may include a needle that extends through the collar, and the needle may include the tip.

[0011] Another general aspect includes a system for crimping a stopper on a syringe and for fluidly connecting an interior of the syringe to a pressure source. The system includes a cap that may include a connector configured to connect the syringe to crimp the stopper on the syringe. The connector defines an interior. The cap includes a spike that extends along a longitudinal axis of the cap. The spike is movably disposed along the longitudinal axis of the cap within the interior of the connector between a first position and a second position. The spike is hollow and may include a tip and a collar spaced from the tip. The system also includes an adapter that is hollow and that is configured to abut against the collar of the spike to fluidly connect the adapter and the spike. The adapter may include a seal extending around the adapter. When the connector is connected to the syringe and when the spike is in the first position, the tip of the spike is spaced from an inner surface of the stopper. When the connector is connected to the syringe and when a force is applied to the adapter to move the adapter and to move the spike from the first position to the second position, the tip of the spike extends entirely through the stopper to fluidly connect the spike and the interior of the syringe.

[0012] Implementations may include one or more of the following features. The adapter defines a channel and the seal is held within the channel. The spike may include a needle that is configured to extend into an interior of the adapter to fluidly connect the interior of the adapter to a hollow interior of the needle. The adapter may include a firstAtty Docket No.202300081-WO portion configured to be at least partially received within an interior of the collar. The cap may include arms that are deflectable. The arms may include protrusions that are configured to hold the spike in the first position. When a force is applied to the spike via the force applied to the adapter, the arms are configured to deflect to permit the spike to move from the first position to the second position. When the spike is in the second position, the protrusions of the arms are configured to hold the spike in the second position and to grasp the adapter. An exterior of the arms may include a connector. The adapter may include a skirt with a connector that is complimentary to the connector of the exterior of the arms. The connector of the skirt is configured to connect with the connector of the exterior of the arms when the adapter moves the spike to the second position to hold the spike in the second position. The system may include an engagement collar configured to attach to the cap. When the engagement collar is attached to the cap in a locked configuration, the engagement collar prevents deflection of the arms and holds the spike in the first position. When the engagement collar is attached to the cap in an unlocked configuration the engagement collar permits deflection of the arms and allows the spike to move from the first position to the second position. The engagement collar may include a stop. When the engagement collar is in the locked configuration, the stop of the engagement collar engages with at least one of the spike or the adapter to block fluid communication between the adapter and the spike. When the engagement collar is in the unlocked configuration, the stop of the engagement collar is disengaged with the at least one of the spike or the adapter to permit fluid communication between the adapter and the spike.

[0013] There has thus been outlined certain embodiments of the present disclosure in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional embodiments of the present disclosure that will be described below, and which form the subject matter of the claims appended hereto.

[0014] In this respect, before explaining at least one aspect of the present disclosure in detail, it is to be understood that the embodiments described herein are not limited in their application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The caps and systemsAtty Docket No.202300081-WO of this disclosure are capable of aspects in addition to those described, and of being practiced and carried out in various ways. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order that the present disclosure may be readily understood, aspects are illustrated by way of examples in the accompanying drawings, in which like parts are referred to with like reference numerals throughout.

[0016] FIG. 1 shows a schematic cross section view of a syringe, cap, and adapter with a spike in a first position.

[0017] FIG. 2 shows a schematic cross section view of the syringe, cap, and adapter of FIG. 1 with the spike in a second position.

[0018] FIG. 3 shows a schematic cross section view of the syringe, cap, and adapter of FIG. 1 with the spike in a second position and with a substance ejected from the syringe due to pressure exerted on a stopper of the syringe from a pressure source.

[0019] FIG. 4 shows a cross section view of a system with an engagement collar in a locked configuration and a spike in the first position.

[0020] FIG. 5 shows a cross section view of the system of FIG.4 with the engagement collar in an unlocked configuration and the spike in the second position.

[0021] FIG. 6 shows a cross section view of a second embodiment of the cap and a second embodiment of the adapter with the spike in the first position.

[0022] FIG. 7 shows a cross section view of the second embodiment of the cap and the second embodiment of the adapter with the spike in the second position.

[0023] FIG. 8 shows a cross section view of a third embodiment of the cap and a third embodiment of the adapter with the spike in the first position.

[0024] FIG. 9 shows a cross section view of the third embodiment of the cap and the third embodiment of the adapter with the spike in the second position.

[0025] FIG. 10 shows a cross section view of a fourth embodiment of the cap and a fourth embodiment of the adapter with the spike in the first position.

[0026] FIG. 11 shows a cross section view of the fourth embodiment of the cap and the fourth embodiment of the adapter with the spike in the second position.Atty Docket No.202300081-WO

[0027] FIG. 12 shows a cross section view of a fifth embodiment of the cap and a fifth embodiment of the adapter with the spike in the first position.

[0028] FIG. 13 shows a cross section view of the fifth embodiment of the cap and the fifth embodiment of the adapter with the spike in the second position. DETAILED DESCRIPTION

[0029] The present disclosure is directed to caps and systems that can selectively fluidly connect a primary container with a pressure source for controlling ejection of a substance from the primary container. The terms “primary container” and syringe can be used interchangeably in this disclosure and can refer to a syringe or any other container.

[0030] The caps and systems according to aspects of this invention can include a connector that can connect to the syringe to crimp a stopper on the syringe. This can, in embodiments, help maintain container closure integrity during cryogenic storage and during thawing, such as for bioprinting applications. The caps and systems according to aspects of this invention can include a spike that can be movably disposed within an interior of the connector between a first position and a second position. The spike can be hollow and can include a tip and a collar that can be spaced proximally from the tip. The collar can abut against an adapter to fluidly connect the adapter and the spike.

[0031] When the connector is connected to the syringe to crimp the stopper on the syringe and the spike is in the first position, the tip of the spike can be spaced proximally from the stopper. According to this configuration, container closure integrity of the syringe can be maintained since spacing of the stopper from the tip of the spike can reduce the risk of accidental puncture of the stopper before use. When the connector is connected to the syringe to crimp the stopper on the syringe and the spike is moved to the second position, the tip of the spike can extend through the stopper to fluidly connect the spike and an interior of the syringe. This can provide a pathway for controlling the ejection of substances (e.g., bioink, medicaments, etc.) from the syringe using a working fluid pressurized by the pressure source. These and other aspects of the disclosure are described as follows in reference to FIGS.1–13.

[0032] FIGS.1–3 show schematic cross section views of a syringe 100 with a cap 200 and an adapter 300. FIG.1 shows a schematic cross section view of the syringe 100,Atty Docket No.202300081-WO cap 200, and adapter 300 with a spike 202 of the cap 200 in a first position. FIG.2 shows a schematic cross section view of the syringe 100, cap 200, and adapter 300 with the spike 202 in a second position piercing a stopper 114 of the syringe 100. FIG. 3 shows a schematic cross section view of the syringe 100, cap 200, and adapter 300 with the spike 202 in the second position and a pressure source 10 controlling ejection of a substance 101 from the syringe 100 via the adapter 300 and cap 200.

[0033] The cap 200 can crimp the stopper 114 on the syringe 100 and can selectively fluidly connect the syringe 100 to the adapter 300. The cap 200 can crimp the stopper 114 on the syringe 100 to maintain container closure integrity of a proximal opening 106 of the syringe 100. The term “container closure integrity” as used herein can mean that the interior of the container (e.g., the syringe 100) is closed off from the outside environment so as not to exchange solids, liquids, and / or gases between an interior of the container and the outside environment. The cap 200 can crimp the stopper 114 to the syringe 100 to maintain container closure integrity of the proximal opening 106 during cryogenic storage and during thawing. This can include maintaining container closure integrity within a temperature range of between -196°C and 37°C. In embodiments, maintaining container closure integrity during cryogenic storage and during thawing can include maintaining container closure integrity at all temperatures between -196°C and 37°C.

[0034] In embodiments, the cap 200 and the adapter 300 can be provided together in a system 1 that can crimp the stopper 114 on the syringe 100 and can selectively fluidly connect the syringe 100 to a pressure source 10.

[0035] The cap 200 can include a connector 204. The connector 204 can connect to the syringe 100 to crimp the stopper 114 on the syringe 100. In embodiments, the connector 204 can be a snap fit connector, a threaded connector, an energized spring fit connector, among other possibilities.

[0036] The cap 200 can include the spike 202. The spike 202 can extend along a longitudinal axis of the cap 200. The spike 202 can be movably disposed along the longitudinal axis of the cap 200 within an interior 206 of the connector 204. For example, the connector 204 can include arms 208 that extend proximally. The interior 206 can be defined, at least partially, by a region between the arms 208. The spike 202 can include a tip 210 that can pierce the stopper 114. The spike 202 can also include a collar 212 thatAtty Docket No.202300081-WO extends proximally from the tip 210. In embodiments, the collar 212 and the tip 210 can be integral. In embodiments, the collar 212 can be a distinct structure from the tip 210. For example, the spike 202 can include a needle that extends through the collar 212 and the needle can include the tip 210. In embodiments, the collar 212 can define an interior that can receive the adapter 300. The spike 202 can be hollow and can communicate fluid through an opening in the tip 210. For example, the collar 212 can abut against the adapter 300, which can fluidly connect the adapter 300 and the spike 202. The spike 202 can communicate fluid received from the adapter 300 out of the opening in the tip 210. In embodiments, the collar 212 can include a surface 214 that faces a proximal direction. The adapter 300 can include a surface 302 that faces a distal direction. The surface 214 of the collar 212 can abut the surface 302 of the adapter 300 to fluidly connect the spike 202 and the adapter 300.

[0037] The adapter 300 can fluidly connect the pressure source 10 with an interior of the spike 202. The adapter 300 can be hollow. The adapter 300 can include a seal 304 that can form a seal with the cap 200 (e.g., the arms 208, an interior of the collar 212, among other possibilities). The adapter 300 can define a channel 306 that receives and / or retains the seal 304.

[0038] FIG. 1 shows the spike 202 in a first position with the connector 204 connected to the syringe 100 to crimp the stopper 114 on the syringe 100. In the first position, the tip 210 of the spike 202 can be spaced proximally from at least the inner surface of the stopper 114 (i.e., the surface of the stopper 114 facing the interior of the barrel 102 of the syringe 100) and in embodiments spaced from the outer surface of the stopper 114 (i.e., the surface of the stopper 114 opposing the inner surface of the stopper 114 and facing the proximal direction) . This can help to maintain container closure integrity of the syringe 100 by reducing the risk of the tip 210 prematurely puncturing the stopper 114. In alternative embodiments, the tip 210 of the spike 202 can abut against the stopper 114 when the spike 202 is in the first position.

[0039] FIG. 2 shows the spike 202 in the second position with the connector 204 connected to the syringe 100 to crimp the stopper 114 on the syringe 100. In the second position, the tip 210 of the spike 202 can extend entirely through the stopper 114 to fluidly connect the spike 202 with an interior of the syringe 100. The spike 202 can beAtty Docket No.202300081-WO moved from the first position to the second position when the adapter 300 is engaged with the connector 204 and pressed distally towards the syringe 100. That is, when a force is applied to the adapter 300 in the distal direction the adapter 300 can engage with the spike 202 (e.g., with the collar 212) and move the spike 202 from the first position to the second position to pierce the stopper 114 and fluidly connect the interior of the syringe 100 with a pressure source 10. In embodiments, the pressure source 10 can be a pneumatic printer, though other devices for controlling ejection of the substance 101 from the syringe 100 are possible.

[0040] As shown in FIG.3, the pressure source 10 can be fluidly connected to the adapter 300 via, for example, a supply line 11. The term “fluidly connected” as used herein can include the plain and ordinary meaning of the term, which can include connected in a manner that allows fluid to be communicated from one structure to the other such as for example pneumatically. Pressure can be applied (e.g., pneumatically via a working fluid) to a piston 118 of the syringe 100 via a pathway that includes the supply line 11, an interior of the adapter 300, an interior of the spike 202, and an interior of a barrel 102 of the syringe 100. The applied pressure can move the piston 118 distally to eject the substance 101. This configuration can allow precise ejection control of the substance 101 with forces sufficient to eject viscous substances 101 from the syringe 100.

[0041] As described previously, the connector 204 can include arms 208 that extend proximally. The arms 208 can be deflectable. The arms 208 can hold the spike 202 in the first position and / or in the second position. For example, in embodiments the arms 208 can be biased towards a central axis A of the connector 204, which can squeeze the spike 202 and to hold the spike in the first position and / or in the second position. In embodiments, the arms 208 can include a feature (e.g., a protrusion, groove, indentation, among other possibilities) in an inner surface of the arms 208 that can retain the spike 202 in the first position and / or the second position. In embodiments, protrusions can hold the spike 202 in the first position and / or in the second position. The protrusions can deflect inwardly into the interior 206 of the connector 204 towards the central axis A. For example, when the spike 202 is in the first position protrusions of the arms 208 can be disposed below the collar 212 of the spike 202 to resist distal movement of the spike 202 and hold the spike 202 in the first position. When a force of sufficient magnitude isAtty Docket No.202300081-WO applied to the spike 202 (e.g., via the adapter 300), the spike 202 can deflect the arms 208 outwardly away from the central axis A to release engagement of the protrusions with the collar 212 of the spike 202 and thereby allow the spike 202 advance distally within the interior 206 of the connector 204. When the spike 202 advances to the second position, the protrusions can be disposed proximally with respect to the collar 212 and the arms 208 can deflect back towards the central axis A of the connector 204. The protrusions can engage with a proximal portion of the collar 212 when the spike 202 is in the second position to hold the spike 202 in the second position.

[0042] The syringe 100 is an example of a primary container system of this invention. In embodiments, the syringe 100 can maintain container closure integrity during storage and during thawing. Maintaining container closure integrity during cryogenic storage and during thawing can include maintaining container closure integrity within a temperature range of between -196°C and 37°C. In embodiments, maintaining container closure integrity during cryogenic storage and during thawing can include maintaining container closure integrity at all temperatures between -196°C and 37°C.

[0043] The syringe 100 can include the barrel 102. The barrel 102 can contain the substance 101 such as a bioink, a medicament, etc. The term “bioink” as used herein can refer tissue structures, living cells, extracellular matrix components, biomaterials, hydrogels, extracellular proteins, growth factors, other bioactive components, other non- bioactive components, combinations thereof, etc. Due the container closure integrity provided at cryogenic temperatures by the caps and systems of this disclosure, the substance 101 can include living cells during storage, which can ensure sterility of the substance 101 since the living cells would not need to be added between storage and use. Put differently, the caps and systems of this disclosure can provide the opportunity to pre- mix living cells with other components of the substance 101 and fill and store in the cryogenic conditions for long periods and use in a true ready-to-use state, which can significantly reduce the possibilities of contamination and variation.

[0044] The barrel 102 can include a proximal end 104 that defines a proximal opening 106. The proximal end 104 can include a flange 105. The barrel 102 can include a distal end 108 that defines a distal opening 110. The distal opening 110 can include a connector 112. The barrel 102 can comprise a polymer, glass, or other materials. ForAtty Docket No.202300081-WO example, in embodiments the barrel 102 can comprise a cyclic olefin polymer, a cyclic olefin copolymer, and / or a polypropylene.

[0045] The syringe 100 can include a stopper 114. The stopper 114 can be provided at the proximal end 104 and can seal the proximal opening 106. The stopper 114 can seal the proximal opening 106 using any number of techniques. For example, and in embodiments such as shown in FIG.1, the stopper 114 can be crimped to the proximal end 104 of the barrel 102 to seal the proximal opening 106. The stopper 114 can be pierceable. For example, a central portion 117 of the stopper 114 can be pierced. The stopper 114 can be formed of any number of materials. For example, the stopper 114 can comprise an elastomeric polymer, a fluoropolymer (e.g., PTFE, PCTFE, FEP), a cyclic olefin polymer, a cyclic olefin copolymer, and / or a polypropylene.

[0046] The syringe 100 can include a cap 116. The cap 116 can be removably connected to the connector 112. The cap 116 can seal the distal opening 110. For example, the cap 116 and the connector 112 can each include respective complementary Luer lock connections to provide the removable connection between the cap 116 and the connector 112. Other connection types are possible including other threaded fittings, snap-fits, energized spring fits, etc. The stopper 114 and the cap 116 can respectively seal the proximal opening 106 and the distal opening 110 to maintain container closure integrity at each of the proximal opening 106 and the distal opening 110. The stopper 114 and the cap 116 can maintain the container closure integrity at each of the proximal opening 106 and the distal opening 110 during cryogenic storage and during thawing. As explained previously, this can include maintaining the container closure integrity at each of the proximal opening 106 and the distal opening 110 throughout a temperature range between -196°C and 37°C. In embodiments, the temperature range can at least include all temperatures between -196°C and 37°C. In embodiments, the temperature range can include all temperatures between -196°C and 37°C and at least some temperatures below -196°C and / or above 37°C.

[0047] The cap 116 can comprise any number of materials that can maintain the seal of the distal opening 110. In embodiments, the cap 116 can comprise the same material as the material that forms the connector 112. For example, the connector 112 can be formed of a polymer (e.g., a cyclic olefin polymer) and the cap 116 can be formed of the sameAtty Docket No.202300081-WO polymer (e.g., a cyclic olefin polymer). Since the connector 112 and the cap 116 can be formed of some or all of the same materials, the connector 112 and the cap 116 can expand and / or contract at similar rates to preserve container closure integrity at the distal opening 110. In embodiments, the cap 116 can include an O-ring between the distal opening 110 and the cap 116. The cap 116 can include a cap insert (not shown) that is adjacent to the distal opening 110 when the cap 116 is sealed against the connector 112. The O-ring and the cap insert can be comprised of an elastomer or functionally equivalent material.

[0048] The syringe 100 can include a piston 118. The piston 118 can be provided within the barrel 102. As discussed further herein, pressure can be applied (e.g., pneumatically) through the proximal opening 106 to a proximal surface of the piston 118 to move the piston 118 distally and eject the substance 101 from the syringe 100. The piston 118 can be formed of any number of materials. For example, the piston 118 can comprise an elastomeric polymer, a fluoropolymer (e.g., PTFE, PCTFE, FEP), a cyclic olefin polymer, a cyclic olefin copolymer, and / or a polypropylene.

[0049] In embodiments, the syringe 100 can include a filter (not shown). The filter can be provided within the barrel 102 between the proximal opening 106 and the proximal surface of the piston 118. The filter can reduce or prevent contamination distal to the filter within the interior of the barrel 102. In embodiments, the filter can have a SRUH^VL]H^RI^EHWZHHQ^^^^^DQG^^^^^^P^^)RU^H[DPSOH^^WKH^ILOWHU^FDQ^KDYH^D^SRUH^VL]H^RI^^^^^^ ^P^^The spike 202 can be dimensioned such that when the spike 202 is in the second position the spike 202 pierces both the stopper 114 and the filter, but does not contact the piston 118. That is, the connector 204 can support the spike 202 at a position in which the tip 210 is within the barrel 102 distal to the filter and proximal to the piston 118 when the syringe 100 is filled with the substance 101. For example, the spike 202 can have a length in the longitudinal direction of between 0.25 cm and 4 cm, including for example 0.5 cm. In embodiments, the spike 202 can have a diameter of between 1–5 mm.

[0050] FIGS. 4 and 5 show cross section schematic views of a system 2 in accordance with aspects of this invention. FIG.4 shows the system 2 with an engagement collar 20 in a locked configuration and the spike 202 in the first position. FIG.5 shows the system 2 with the engagement collar 20 in an unlocked configuration and the spikeAtty Docket No.202300081-WO 202 in the second position. The system 2 can include any of the aspects, structures, features, and relationships described previously in reference to the system 1 including for example the syringe 100, the cap 200, and the adapter 300. The system 2 can also include the engagement collar 20, which can be configured to attach to the cap 200. For example, the engagement collar 20 can be aligned coaxially with the cap 200 and can slide over the cap 200 to attached thereto. Other attachment configurations are possible including for example a threaded connection, a snap fit connection, an energized-spring connection, among other possibilities.

[0051] The engagement collar 20 can be arranged in the locked configuration, such as shown in FIG.4. In the locked configuration, the engagement collar 20 can prevent deflection of the arms 208 radially outwardly relative to the central axis of the connector 204. According to this configuration, the engagement collar 20 can hold the arms 208 in an engaged configuration with the spike 202 (e.g., with the collar 212) that resists and / or prevents movement of the spike 202 in the distal direction. The engagement collar 20 can thus limit or prevent premature piercing of the stopper 114.

[0052] The engagement collar 20 can be arranged in the unlocked configuration, such as shown in FIG. 5. In the unlocked configuration, the engagement collar 20 can release the arms 208 to allow the arms to move radially outwardly relative to the central axis of the connector 204. According to this configuration, the engagement collar 20 can release the arms 208 from the engaged configuration with the spike 202 (e.g., with the collar 212) to allow movement of the spike 202 in a distal direction to move the spike 202 from the first position to the second position, as described previously.

[0053] In embodiments, the engagement collar 20 can include a stop 22, such as a nub, a ball, among other possibilities. In the locked configuration such as shown in FIG. 4, the stop 22 can be interposed between the interior of the adapter 300 and the interior of the spike 202 to prevent fluid communication between the adapter 300 and the spike 202. The stop 22 can be translatable (e.g., laterally). For example, when the engagement collar 20 is arranged in the unlocked configuration such as shown in FIG.5 the stop 22 can be translated away from the interior of the adapter and the interior of the spike 202 to allow fluid communication between the adapter 300 and the spike 202. According to thisAtty Docket No.202300081-WO configuration, the stop 22 can serve as a safety to prevent premature piercing of the stopper 114.

[0054] In embodiments, the engagement collar 20 can include a lever that can be rotated to unlock the engagement collar 20. In embodiments, rotation of the engagement collar 20 can both unlock the engagement collar 20 and move the spike 202 from the first position to the second position. For example, a 180° rotation of the engagement collar 20 can unlock the engagement collar 20 and move the spike 22 from the first position to the second position thereby piercing the stopper 114. In embodiments, the engagement collar 20 can include an indicator (audial and / or visual) that can indicate to a user whether the engagement collar 20 is in the locked or unlocked configuration.

[0055] FIGS. 6 and 7 show cross section schematic views of a second embodiment of the cap 400 on the syringe 100 and a second embodiment of the adapter 500. FIG. 6 shows the second embodiment of the cap 400 and the second embodiment of the adapter 500 with the spike 402 in the first position. FIG.7 shows the second embodiment of the cap 400 and the second embodiment of the adapter 500 with the spike 402 in the second position. The cap 400 and the adapter 500 can include any of the aspects, structures, features, and relationships described previously in reference to the cap 200 and the adapter 300, respectively, and vice versa (except where clearly mutually exclusive). For example, the cap 400 can include the spike 402 with the tip 410 and the collar 412, the connector 404, the interior 406, and the arms 408. The adapter 500 can include the seal 504 and the channel 506.

[0056] As described previously, the arms 408 can include protrusions that can hold the spike 402 in the first position or the second position. For example, the arms 408 can include first protrusions 416 at a proximal end of the arms 408. The arms 408 can include second protrusions 418 located distally from the first protrusions 416. In embodiments, the second protrusions 418 can be distanced distally from the first protrusions 416 by an amount greater than or equal to a length of the collar 412. According to this configuration, the first protrusions 416 and the second protrusions 418 can hold the spike 402 (e.g., the collar 412) therebetween to secure the spike 402 in the first position, as shown in FIG.6. Upon application of a distal force, for example from the adapter 500, the arms 408 can deflect outwardly relative to the central axis of the connector 404 toAtty Docket No.202300081-WO allow the spike 402 (e.g., the collar 412) to move distally past the second protrusions 418 and into the second position. When in the second position, the arms 408 can revert towards the central axis of the connector 404 and the second protrusions 418 can secure the spike 402 (e.g., the collar 412) in the second position, as shown in FIG.6.

[0057] As described previously, the spike 402 can include a needle 420 that is distinct from the collar 412. The needle 420 can include the tip 410 at a distal end and a proximal end that extends through the collar 412 and opens into an interior 422 defined by the collar 412.

[0058] In embodiments, the interior 422 defined by the collar 412 can receive the adapter 500. For example, the seal 504 of the adapter 500 can engage with the collar 412 within the interior 422 to reduce or eliminate the risk of blowback of the working fluid in the proximal direction.

[0059] FIGS. 8 and 9 show cross section schematic views of a third embodiment of the cap 600 on the syringe 100 and a third embodiment of the adapter 700. FIG.8 shows the third embodiment of the cap 600 and the third embodiment of the adapter 700 with the spike 602 in the first position. FIG.9 shows the third embodiment of the cap 600 and the third embodiment of the adapter 700 with the spike 602 in the second position. The cap 600 and the adapter 700 can include any of the aspects, structures, features, and relationships described previously in reference to the caps 200, 400 and the adapters 300, 500, respectively, and vice versa (except where clearly mutually exclusive). For example, the cap 600 can include the spike 602 with the tip 610, the collar 612 and the interior 622 defined by the collar 612, the connector 604, the interior 606, the arms 608, the first protrusions 616, and the second protrusions 618. The adapter 700 can include the seal 704 and the channel 706.

[0060] As described previously and as shown in FIGS. 8 and 9, the collar 612 and the tip 610 can be an integral structure.

[0061] In embodiments, the adapter 700 can include a first portion 708 and a second portion 710. The first portion 708 can be dimensioned to be at least partially received within the interior 622 defined by the collar 612. The second portion 710 can be dimensioned larger than the dimensions of the interior 622 defined by the collar 612. In embodiments, the second portion 710 can be radially wider than the first portion 708.Atty Docket No.202300081-WO According to this configuration, the first portion 708 can seal the adapter 700 within the interior 622 defined by the collar 612 using for example the seal 704.

[0062] In embodiments, the second portion 710 can be dimensioned to be received within the interior 606 when the adapter 700 moves the spike 602 from the first position to the second position. According to this configuration, the first protrusions 616 can hold the second portion 710 when the spike 602 has been moved by the adapter 700 to the second position to secure the adapter 700 to the cap 600 and maintain the fluid connection therebetween.

[0063] FIGS.10 and 11 show cross section schematic views of a fourth embodiment of the cap 800 on the syringe 100 and a fourth embodiment of the adapter 900. FIG. 10 shows the fourth embodiment of the cap 800 and the fourth embodiment of the adapter 900 with the spike 802 in the first position. FIG. 11 shows the fourth embodiment of the cap 800 and the fourth embodiment of the adapter 900 with the spike 802 in the second position. The cap 800 and the adapter 900 can include any of the aspects, structures, features, and relationships described previously in reference to the caps 200, 400, 600 and the adapters 300, 500, 700, respectively, and vice versa (except where clearly mutually exclusive). For example, the cap 800 can include the spike 802 with the tip 810, the collar 812 and the interior 822 defined by the collar 812, the connector 804, the interior 806, the arms 808, the first protrusions 816, and the second protrusions 818. The adapter 900 can include the seal 904, the channel 906, the first portion 908, and the second portion 910.

[0064] As shown in FIGS.10 and 11, the second portion 910 can form a skirt that can extend around an exterior of the arms 808 when the adapter 900 moves the spike 802 into the second position. In embodiments, the second portion 910 can include a connector 912 that can engage with a complementary connector 824 of the of the arms 808 when the adapter 900 moves the spike 802 into the second position. The connector 912 and the connector 824 can be snap fit connections (e.g., protrusion(s) with complementary recess(es)), threaded connections, energized spring fit connections, among other possibilities. According to this configuration, when the adapter 900 moves the spike 802 into the second position the connector 824 can engage with the connector 912 to hold the adapter 900 in place and maintain the fluid connection between the adapter 900 and the spike 802.Atty Docket No.202300081-WO

[0065] In embodiments such as shown in FIGS.10 and 11, the connector 804 can be configured to align the spike 802 and the stopper 114 such that the spike 802 pierces through the central portion of the stopper 114 when the connector when the spike 802 moves from the first position to the second position. For example, the interior 806 defined by the connector 804 can taper towards the central axis of the connector 804 from the proximal to the distal direction.

[0066] FIGS.12 and 13 show cross section schematic views of a fifth embodiment of the cap 1000 on the syringe 100 and a fifth embodiment of the adapter 1100. FIG.12 shows the fifth embodiment of the cap 1000 and the fifth embodiment of the adapter 1100 with the spike 1002 in the first position. FIG. 13 shows the fifth embodiment of the cap 1000 and the fifth embodiment of the adapter 1100 with the spike 1002 in the second position. The cap 1000 and the adapter 1100 can include any of the aspects, structures, features, and relationships described previously in reference to the caps 200, 400, 600, 800 and the adapters 300, 500, 700, 900, respectively, and vice versa (except where clearly mutually exclusive). For example, the cap 1000 can include the spike 1002 with the tip 1010, the collar 1012 and the interior 1022 defined by the collar 1012, the connector 1004, the interior 1006, the arms 1008 with the connectors 1024, the first protrusions 1016, and the second protrusions 1018. The adapter 1100 can include the seal 1104, the channel 1106, the first portion 1108, and the second portion 1110 with the connector 1112.

[0067] In embodiments, the second portion 1110 can extend between a quarter and a half, or at least half the length of the arms 1008 when the adapter 1100 moves the spike 1002 to the second position. According to this configuration, the adapter 1100 can strongly secure the arms 1008 and retain the spike 1002 in the second position.

[0068] While certain implementations of the invention have been described, the present disclosure is not limited to these disclosed aspects. Additional modifications and improvements to the disclosure may be apparent to those skilled in the art. Moreover, the many features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the present disclosure which fall within the spirit and scope of the disclosure.

Claims

Atty Docket No.202300081-WO What is claimed is:

1. A cap for crimping a stopper on a syringe and for fluidly connecting the syringe to an adapter, the cap comprising: a connector configured to connect to the syringe to crimp the stopper on the syringe, the connector defining an interior; and a spike that extends along a longitudinal axis of the cap, the spike being movably disposed along the longitudinal axis within the interior of the connector between a first position and a second position, the spike being hollow and comprising a tip and a collar spaced from the tip, the collar being configured to abut against the adapter to fluidly connect the adapter and the spike, wherein: when the connector is connected to the syringe and the spike is in the first position, the tip of the spike is spaced from an inner surface of the stopper, and when the connector is connected to the syringe and the spike is in the second position, the tip of the spike extends through the stopper to fluidly connect the spike and the syringe.

2. The cap of claim 1, wherein: the connector comprises arms that are deflectable, the arms are configured to hold the spike in the first position, and when a force is applied to the spike, the arms are configured to deflect to permit movement of the spike from the first position to the second position.

3. The cap of claim 2, wherein the arms comprise protrusions that project inwardly into the interior defined by the connector.

4. The cap of claim 3, wherein at least one of the protrusions is configured to hold the spike in the first position.Atty Docket No.202300081-WO 5. The cap of claim 3, wherein the at least one of the protrusions is configured to hold the spike in the second position after the force is applied to the spike to move the spike from the first position to the second position.

6. The cap of claim 1, wherein the collar defines an interior that is configured to receive the adapter.

7. The cap of claim 6, wherein the collar comprises a surface that is configured to abut against a surface of the adapter.

8. The cap of claim 1, wherein the tip and the collar are integral.

9. The cap of claim 1, wherein the spike comprises a needle that extends through the collar, and the needle comprises the tip.

10. A system for crimping a stopper on a syringe and for fluidly connecting an interior of the syringe to a pressure source, the system comprising: a cap comprising: a connector configured to connect the syringe to crimp the stopper on the syringe, the connector defining an interior; and a spike that extends along a longitudinal axis of the cap, the spike being movably disposed along the longitudinal axis of the cap within the interior of the connector between a first position and a second position, the spike being hollow and comprising a tip and a collar spaced from the tip; and an adapter that is hollow and that is configured to abut against the collar of the spike to fluidly connect the adapter and the spike, the adapter comprising a seal extending around the adapter, wherein: when the connector is connected to the syringe and when the spike is in the first position, the tip of the spike is spaced from an inner surface of the stopper, andAtty Docket No.202300081-WO when the connector is connected to the syringe and when a force is applied to the adapter to move the adapter and to move the spike from the first position to the second position, the tip of the spike extends entirely through the stopper to fluidly connect the spike and the interior of the syringe.

11. The system of claim 10, wherein the adapter defines a channel and the seal is held within the channel.

12. The system of claim 10, wherein the spike comprises a needle that is configured to extend into an interior of the adapter to fluidly connect the interior of the adapter to a hollow interior of the needle.

13. The system of claim 10, wherein the adapter comprises a first portion configured to be at least partially received within an interior of the collar.

14. The system of claim 10, wherein: the cap comprises arms that are deflectable, the arms comprise protrusions that are configured to hold the spike in the first position, and when a force is applied to the spike via the force applied to the adapter, the arms are configured to deflect to permit the spike to move from the first position to the second position.

15. The system of claim 14, wherein, when the spike is in the second position, the protrusions of the arms are configured to hold the spike in the second position and to grasp the adapter.

16. The system of claim 14, wherein: an exterior of the arms comprises a connector, the adapter comprises a skirt with a connector that is complimentary to the connector of the exterior of the arms, andAtty Docket No.202300081-WO the connector of the skirt is configured to connect with the connector of the exterior of the arms when the adapter moves the spike to the second position to hold the spike in the second position.

17. The system of claim 14, further comprising an engagement collar configured to attach to the cap.

18. The system of claim 17, wherein: when the engagement collar is attached to the cap in a locked configuration, the engagement collar prevents deflection of the arms and holds the spike in the first position, and when the engagement collar is attached to the cap in an unlocked configuration the engagement collar permits deflection of the arms allows the spike to move from the first position to the second position.

19. The system of claim 18, wherein the engagement collar comprises a stop.

20. The system of claim 19, wherein: when the engagement collar is in the locked configuration, the stop of the engagement collar engages with at least one of the spike or the adapter to block fluid communication between the adapter and the spike, and when the engagement collar is in the unlocked configuration, the stop of the engagement collar is disengaged with the at least one of the spike or the adapter to permit fluid communication between the adapter and the spike.

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