Closed-type liquid delivery device and system

KR103005255B1Active Publication Date: 2026-08-14WEST PHARM SERVICES IL LTD
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Patent Information

Application Number
KR1020247031208
Authority / Receiving Office
KR · KR
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-02-18
Filing Date
2023-02-18
Publication Date
2026-08-14
Estimated Expiration
2043-02-18

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Abstract

A closed-system liquid delivery device is used with an infusion container containing the infusion liquid, a drug source containing the drug, and an infusion set, respectively. The closed-system liquid delivery device includes first, second, and third connectors that connect the infusion container, the infusion set, and the drug source, respectively, and resist removal.
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Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] This application claims the benefit of U.S. provisional patent application no. 63 / 311,802 filed on February 18, 2022, the disclosure of which is incorporated herein by reference.

[0003] Technology field

[0004] The present invention generally relates to a closed-type liquid delivery device and system, in particular to safely deliver a drug to an infusion container and from the infusion container to an infusion set. Background Technology

[0005] Closed Sterile Delivery Devices (CSTDs) can be important for use with medicates (e.g., drugs, vaccines, etc.), including certain chemotherapy drugs. CSTDs can limit the potential exposure of personnel manufacturing or administering hazardous medications. Devices exist that allow various medications to be delivered to an infusion vessel and then from the vessel to an infusion set, enabling the intravenous supply of the medication to a patient along with the infusion fluid. For example, medication can be supplied to an infusion vessel via a syringe connected to a fitting. The fitting can be connected to the infusion vessel, the medication source, and the infusion set. However, the connections between the fitting and each of the infusion vessel, medication source, and infusion set may not be sufficiently strong and can be dislodged when subjected to relatively small removal forces. This can cause safety or contamination issues, particularly when the medication is hazardous.

[0006] Therefore, there is a need for a closed liquid delivery device that connects safely and universally to the infusion vessel, drug source, and infusion set, and can resist the removal of these connections to prevent tampering of the drug and / or infusion fluid. There is also a need for one or more connections that allow for closed sterile delivery of the drug.

[0007] These requirements are largely satisfied by a closed-system liquid delivery device configured for use with each of an infusion container that contains an infusion solution and has a port for administering the infusion solution. The closed-system liquid delivery device comprises a main body. The device comprises an IV set spike configured to be fluidically connected to a port of the infusion container at a first end of the main body. The device also comprises a port at a second end of the main body, which may include a locking ring configured to seal and receive the IV set spike of the infusion set and to resist a removal force applied to the port of the closed-system liquid delivery device or to the IV set spike of the infusion set. The device also comprises a female lure at a third end of the main body configured to be fluidly connected to a male lure of a pharmaceutical source.

[0008] An embodiment may include one or more of the following features. The locking ring may have a plurality of circumferential ridges. The plurality of circumferential ridges may be provided on the inner surface of the locking ring, and the locking ring may be provided within a recess of a port of a closed-system liquid delivery device. The recess may be tapered. Translational movement of the locking ring toward the narrow part of the recess may reduce the diameter of the locking ring. The locking ring may include a lateral slit. The female lure may include a plurality of protrusions configured to resist rotation of the male lure in the open direction. The plurality of protrusions may be arranged in a circumferential thread. The IV set spike of the closed-system liquid delivery device may include a limiting portion having an outwardly protruding trailing edge. The outwardly protruding trailing edge may define a plurality of barbs. The IV set spike of the closed-system liquid delivery device may include: a tip; and one or more ribs between the tip and the limiting portion. The IV set spike of the closed-system liquid delivery device may include an alternating portion, and the opposite end of the limiting portion for the outwardly protruding trailing edge may be adjacent to the alternating portion. The second lumen may be configured to provide fluid communication to the port of the closed-system liquid delivery device, including liquid received from a pharmaceutical source through the first lumen in the infusion container. The locking ring may have an upper side and a lower side. The upper side has an upper projection substantially perpendicular to the plane of the upper side, and the lower side has a lower projection substantially perpendicular to the plane of the lower side, oriented 180° opposite to the upper projection, and located on the opposite portion of the locking ring. The lower projection and the upper projection may have different lengths. The locking ring may be flat and may be positioned within a holder having an opening at its lower end, sized to accommodate the insertion of the IV set spike of the infusion set. The holder may have an inner wall and an inner step.The inner wall may have a diameter larger than the diameter of the opening, and an inner step may be located between the opening and the inner wall. A locking ring may be located at the top of the inner step, and a spring is located at the top of the locking ring. The inner step does not extend more than 25% of the inner wall circumference, and the locking ring has an outer circumference that is 10% or less smaller than the inner wall circumference. The holder is a first holder, and the closed-type system liquid delivery device further includes a second holder accommodated within the first holder. The first holder includes a first connector, and the second holder includes a second connector that is complementary to the first connector and configured to connect with the first connector to connect the first holder and the second holder. The first holder includes a first stopper, and the second holder includes a second stopper that is complementary to the first stopper and configured to engage with the first stopper to prevent relative rotation between the first holder and the second holder. The IV set spike of the closed-type system liquid delivery device includes an arm defining a tooth configured to grip the port of the injection fluid container. The kit may include a closed-system liquid delivery device, an infusion container, a drug source, and an infusion set. The drug source may include a syringe.

[0009] One general embodiment includes a closed-system liquid delivery device configured for use with each of an infusion container containing an infusion solution and having a port for administering the infusion solution. The closed-system liquid delivery device includes a main body. The device also includes an IV set spike at a first end of the main body configured to be fluidically connected to a port of the infusion container. The device also includes a port at a second end configured to seal and receive the IV set spike of the infusion set. The device also includes a female lure at a third end of the main body configured to be fluidly connected to a male lure of a drug source, and the female lure may include a plurality of protrusions configured to resist rotation of the male lure in an open direction.

[0010] An embodiment may include one or more of the following features. A plurality of protrusions may be arranged in a circumferential thread. The female lure further includes a guard. The IV set spike of the closed-system liquid delivery device may include a limiting portion having an outwardly protruding trailing edge. The outwardly protruding trailing edge may include a plurality of barbs. The IV set spike of the closed-system liquid delivery device may include: a tip; and one or more ribs between the tip and the limiting portion. The IV set spike of the closed-system liquid delivery device may include an alternating portion, and the end of the limiting portion opposite to the outwardly protruding trailing edge may be adjacent to the alternating portion. A second lumen may be configured to provide fluid communication to a port of the closed-system liquid delivery device, including liquid received from a drug source through the first lumen in an infusion container. A kit may include a closed-system liquid delivery device, an infusion container, a drug source, and an infusion set. The drug source may include a syringe.

[0011] One general embodiment comprises a fitting having a first connector configured to fluidly connect the fitting to a port of an IV bag; the first connector may include a first opposing portion configured to resist a first force applied to the first connector or port, the first force being at least 30 N. The fitting also comprises a second connector configured to fluidly connect the fitting to an IV set spike of an infusion set, the second connector may include a second opposing portion configured to resist a second force applied to the second connector or IV set spike, the second force being at least 30 N. The fitting also comprises a third connector configured to fluidly connect the fitting to a water lure of a drug source, the second connector may include a third opposing portion configured to resist a third force applied to the second connector or water lure, the third force being at least 30 N. The fitting also comprises a body fluidly connected to the first, second, and third connectors.

[0012] An embodiment may include one or more of the following features. A first connector may define an IV set spike, and a first opposing part may define a limiting part having an outwardly protruding trailing edge configured to be embedded in the port of the IV bag upon application of a first force. A second connector may define a port, and a second opposing part may define a locking ring configured to grip the IV set spike of the injection set. A third connector may define a female lure, and a third opposing part defines a protrusion configured to resist rotation of the male lure in the open direction.

[0013] One general embodiment includes a device for closed sterile delivery of material. The device includes an outer body defining the interior and a channel extending through the outer body and opening into the interior. The device includes a diaphragm sealing the channel of the outer body and an inner body within the interior of the outer body. The inner body defines the interior. The inner body may include: a seal within the interior of the inner body configured to fluidly seal the opening of the container; a projection extending through the seal; and a filter. The projection may include: a first channel fluidly connecting the channel of the outer body and the interior of the inner body; and a second channel fluidly connecting the interior of the outer body and the interior of the inner body. The inner body and the outer body together define a path through which gas can escape from the interior of the inner body, and the path extends through the second channel of the inner body, through the interior of the outer body, through the filter, to the outside of the outlet of the device.

[0014] An embodiment may include one or more of the following features. The device may include a vessel, and the opening of the vessel may include at least one cyclic olefin polymer or cyclic olefin copolymer. The filter extends circumferentially around the central axis of the inner body. The filter may include a hydrophobic medium that prevents fluid from escaping through the outlet. The filter is charged. The filter may include pores with a size of 0.2 μm or less. The filter may include PTFE. The filter is corrugated. The filter is elastic and configured to apply force to the seal to fluidly seal the vessel opening. The device may include a cap configured to be detachably attached to the outer body to cover the diaphragm.

[0015] Various additional features and advantages of the present invention will become apparent to those skilled in the art by reviewing the following detailed description of exemplary embodiments described together with the accompanying drawings. Brief explanation of the drawing

[0016] The following detailed description is better understood when read in conjunction with the attached drawings. For illustrative purposes, examples are shown in the drawings; however, the subject matter is not limited to the specific elements and mechanisms disclosed. In the drawings: FIG. 1 illustrates a schematic representation of a closed-loop liquid delivery system; FIG. 2 illustrates a first embodiment of a first connector; FIG. 3 shows a cross-sectional view of a first embodiment of a first connector fitted to an IV bag; FIG. 4 illustrates a second embodiment of the first connector; FIG. 5 illustrates a third embodiment of the first connector; FIG. 6 illustrates a fourth embodiment of the first connector; FIG. 7 illustrates a fifth embodiment of the first connector; FIG. 8 illustrates a fifth embodiment of a first connector connected to a rigid port; FIG. 9 illustrates a fifth embodiment of a first connector connected to a flexible port; FIG. 10 illustrates a first embodiment of a second connector; FIG. 11 illustrates a locking ring of a first embodiment of a second connector; FIG. 12 shows an exploded view of a second embodiment of the second connector; FIG. 13 illustrates a cross-sectional view of a second embodiment of the second connector; FIG. 14 illustrates a cross-sectional view of a third embodiment of the second connector; FIG. 15 illustrates a cross-sectional view of a third embodiment of the second connector when an IV set spike is inserted; FIG. 16 illustrates a cross-sectional view of a third embodiment of a second connector in which a locking ring is engaged with an IV set spike; FIG. 17 illustrates a cross-sectional view of a fourth embodiment of the second connector; FIG. 18 shows a cross-sectional view of a fifth embodiment of the second connector; FIG. 19 illustrates a cross-sectional view of a first embodiment of a third connector; FIG. 20 illustrates a cross-sectional view of a second embodiment of a third connector; FIG. 21 illustrates a first embodiment of a fitting; FIG. 22 illustrates a second embodiment of the fitting; FIG. 23 illustrates an exploded view of a device for closed-type sterile delivery; and FIG. 24 illustrates the gas moving through the path of the device for closed-type sterile delivery of FIG. 23. Specific details for implementing the invention

[0017] FIG. 1 illustrates a closed liquid delivery system (1) for delivering a drug intravenously. The system (1) may be a kit. The system (1) may include an infusion container, e.g., an intravenous (IV) bag (10), which may contain an infusion solution such as saline or any other fluid that may be administered intravenously to a patient. The system (1) may include an infusion set (20) capable of supplying the infusion solution and / or drug from the IV bag (10) to the patient for intravenous administration of the infusion solution and / or drug. The system (1) may include a drug source (30) (e.g., a container equipped with a syringe, vial, etc.) which may contain a drug that may be administered intravenously to a patient alone and / or in combination with an infusion solution. As used herein, the term “drug” includes the general and common meaning and may also include any other substance that may be administered to a patient alone or in combination with an infusion solution including vitamins, nutrients, electrolytes, etc.

[0018] The system (1) also includes a fitting (100) having a body that can be fluidly connected to any and all of the IV bag (10), the infusion set (20), and the drug source (30) (i.e., physically connected in a manner that allows fluid to flow from one structure to another). The fitting (100) may be a closed liquid delivery device. The fitting (100) may include a monolithic trifurcated connector body that defines a barrel and can be fluidly connected to each of the first connector (110), the second connector (120), and the third connector (130) as described below. The fitting (100) may be formed of a material compatible with the drug and may allow the infusion fluid to flow through the fitting (100). The fitting (100) can provide a closed liquid delivery device that is rigidly and universally connected to an infusion vessel, a drug source, and an infusion set, and can resist removal of these connections to prevent tempering of the drug and / or infusion fluid. Additionally, since the feature securing the connection is part of the fitting (100), the connection to the existing infusion vessel, drug source, and infusion set can be secured without modification to the existing infusion vessel, drug source, and infusion set. This can also improve the comfort of the medical professional administering the drug because the connection is familiar yet rigid.

[0019] As illustrated in FIG. 1, the fitting (100) and the IV bag (10) may be fluidly connected at a connection (A) so that fluid can flow from the IV bag (10) to the body of the fitting (100). For example, the IV bag (10) may include a port (12) that may be sized to comply with any IV port standard, such as one established by the International Organization for Standardization (ISO). The fitting (100) may include a first connector (110) that can be connected to the port (12) to form connection A. The first connector (110) may include a first opposing portion (112) that can resist a force (F1) that may be applied directly or indirectly to the first connector (110) and / or the port (12) in one or more directions to detach connection A, as illustrated in FIG. 1. That is, the first opposing portion (112) can resist the force of F1 to keep connection A together. The first opposing part (112) can resist a force F1 of at least 15N.

[0020] In an embodiment, the first connector (110) may be an IV set spike. The fitting (100) may include a first lumen capable of fluidly connecting the opening of the third connector (130) and the opening positioned at the first distal end of the first connector (110). The fitting (100) may include a second lumen capable of fluidly connecting the second opening positioned at the second distal end of the first connector (110) and the second connector (120). According to this configuration, the communication between the third connector (130) and the IV set spike may be separated from the fluid communication between the second connector (120) and the IV set spike. Through this, the drug may be introduced from the drug source (30) into the IV bag (10) through the third connector (130) and the first lumen and mixed with the infusion liquid to form a drug infusion liquid. Through this, the drug infusion liquid can be subsequently administered to the patient from the IV bag through the second lumen and the second connector (120) to the infusion set (20).

[0021] The first opposing portion (112) may include one or more ribs protruding from the first connector (110). Additionally or alternatively, the opposing portion may include a restrainer that can be snap-fitted around the first connector (110). The restrainer may include one or more outwardly directed tabs or barbs. For example, the restrainer may include a circumferential array of outwardly directed barbs.

[0022] Returning to FIG. 1, the fitting (100) and the injection set (20) may be fluidly connected at connection B to allow fluid to flow from the body of the fitting (100) to the injection set (20). For example, the injection set (20) may include an IV set spike (22) that may be sized to comply with any IV set spike standard, such as one set by ISO. For example, the IV set spike (22) may have an outer diameter of 5 mm. The fitting (100) may include a second connector (120) that may be connected to the IV set spike (22) to form connection B. The second connector (120) may include a second opposing portion (122) capable of resisting a force F2 that may be applied directly or indirectly to the second connector (120) and / or the IV set spike (22) in one or more directions to disconnect connection B as illustrated in FIG. 1. That is, the second opposing part (122) can resist the force F2 and maintain connection B together. The second opposing part (122) can resist the force F2 up to at least 15N.

[0023] In an embodiment, the second connector (120) may be a port that accommodates the IV set spike (22). The second opposing portion (122) may be a locking ring disposed within the port. The locking ring may include an internal circumferential ridge capable of gripping the IV set spike (22). The locking ring may be made of any suitable material, for example, plastic and / or metal. The second connector (120) and / or the second opposing portion (122) may include a taper. For example, the second connector (120) and / or the second opposing portion (122) may taper from the opening of the second connector (120) and / or the second opposing portion (122).

[0024] Returning to FIG. 1, the fitting (100) and the drug source (30) may be fluidly connected at connection C to allow fluid to flow from the drug source (30) to the body of the fitting (100). For example, the drug source (30) may include a male lure (32), which may be sized to comply with any male lure standard, such as a standard set by ISO. The fitting (100) may include a third connector (130) that can be connected to the male lure (32) to form connection C. The third connector (130) may include a third opposing part (132) capable of resisting a force F3 that may be applied directly or indirectly to the third connector (130) and / or the male lure (32) in one or more directions to detach connection C as illustrated in FIG. 1. That is, the third opposing member (132) can resist the force F3 and maintain the connection C together. The third opposing member (132) can resist the force F3 up to the minimum standard required by ISO 11040-4 Annex C2.

[0025] In an embodiment, the third connector (130) may be a female lure that accommodates a male lure (32). The female lure may include a thread. The third opposing portion (132) may be a ring. The ring may include a protrusion such as a pin. The protrusion may be flexible in one direction (e.g., the closing direction) and rigid in the other direction (e.g., the opening direction). According to this configuration, the locking nut of the male lure (32) may be threaded into the third connector (130), and the third opposing portion (132) may resist removal of the locking nut of the male lure (32).

[0026] FIGS. 2 through 9 illustrate embodiments of the first connector (210, 310, 410, 510, 610). Except for mutually exclusive features, embodiments of the first connector (210, 310, 410, 510, 610) may include any of the features described above with reference to the first connector (110) where similar parts correspond to similar parts, and vice versa. Additionally, any one of the first connectors (210, 310, 410, 510, 610) may be used in the system (1) and may be provided as part of the fitting (100) in the same manner as previously described with reference to the first connector (110).

[0027] FIGS. 2 and FIGS. 3 illustrate a view of the first connector (210). The first connector (210) may include a flange (213) and an IV set spike (214) extending proximally from the flange (213). As shown in FIG. 3, the IV set spike (214) may be inserted through the port (12) of the IV bag (10). The IV set spike (214) may include an outer diameter (204). The IV set spike (214) may taper from the outer diameter (204) to the tip (215) of the IV set spike (214). The tip (215) may open the IV bag (10) by puncturing the septum of the port (12) upon sliding insertion into the port (12). The outer diameter (204) of the IV set spike (214) may be less than 5.6 mm. For example, the outer diameter (204) of the IV set spike (214) may be 4.5 mm (+ / -10%).

[0028] The first connector (210) may include a counter portion (212) provided on the IV set spike (214). The counter portion (212) may include one or more ribs (216). The ribs (216) may protrude from the IV set spike (214). The ribs (216) may form a seal to prevent fluid from escaping the IV bag (10) between the IV set spike (214) and the port (12). The ribs (216) may be formed integrally with the IV set spike (214). Alternatively, the ribs (216) may be formed separately from the IV set spike (214) and then secured to the IV set spike (214) with an adhesive or other known fastening technique. The ribs (216) may be formed of a material capable of contacting the infusion fluid and / or the drug without contaminating the infusion fluid or drug. The rib (216) may be formed from the same material that forms the IV set spike (214). Alternatively, the rib (216) may be formed from a different material than the IV set spike (214). The rib (216) may continuously surround the IV set spike (214). Alternatively, the rib (216) may discontinuously surround the IV set spike (214). In an embodiment, the first connector (210) may include three ribs (216), but any number of ribs (216) including one rib (216) or not including any ribs is possible.

[0029] In an embodiment, the opposing portion (212) may additionally or alternatively include a limiting portion (218). The limiting portion (218) may discontinuously surround the IV set spike (214). For example, the limiting portion (218) may include a longitudinal slit that allows the limiting portion (218) to snap-fit ​​around the IV set spike (214). Alternatively, the limiting portion (218) may continuously surround the IV set spike (214).

[0030] The limiting portion (218) may include a trailing edge (219) that protrudes outward. The trailing edge (219) may be tapered toward the tip (215) of the IV set spike (214) and may flare out at an angle beyond the outer surface of the IV set spike (214) away from the tip (215). The trailing edge (219) may be elastically deflectable. For example, when the IV set spike (214) is inserted into the port (12), the trailing edge (219) may be elastically deflected relative to the IV set spike (214), and when the IV set spike (214) is pulled outward relative to the port (12), the trailing edge (219) may be elastically deflected radially away from the IV set spike (214). According to this arrangement, the trailing edge (219) may grip the interior of the port (12) and / or be embedded therein to resist the removal of the IV set spike (214) without significantly hindering the insertion of the IV set spike (214) into the port (12). The trailing edge (219) may include one or more tabs. Additionally or alternatively, the trailing edge (219) may include one or more barbs.

[0031] The limiting portion (218) may be formed of a material different from the material forming the IV set spike (214). For example, the IV set spike (214) may be formed of a material that can come into contact with the infusion fluid and / or drug without contaminating the infusion fluid or drug. The limiting portion (218) may be formed of a different material, such as stainless steel, so that the limiting portion (218) can be arranged on the IV set spike (214) without coming into contact with the infusion fluid and / or drug. For example, the limiting portion (218) may be arranged on the IV set spike (214) with a rib (216) interposed between the tip (215) and the limiting portion (218), so that the rib (216) prevents the infusion fluid and / or drug from coming into contact with the limiting portion (218). Alternatively, the limiting portion (218) may be formed of the same material forming the IV set spike (214).

[0032] In an embodiment, the limiting portion (218) may indicate sufficient insertion of the IV set spike (214) into the port (12). For example, the port (12) may be transparent, and the user may monitor the distance between the limiting portion (218) and the rim of the port (12) to ensure that the IV set spike (214) is sufficiently inserted into the port (12). The distance between the limiting portion (218) and the rim of the port (12) may be, for example, at least 2 mm.

[0033] FIG. 4 illustrates a perspective view of a first connector (310). Except for mutually exclusive features, the first connector (310) may include any or all of the previously described features with reference to the first connector (210) where similar parts correspond to similar parts, and vice versa. For example, the first connector (310) may include a limiting part (318) having an opposing part (312), a flange (313), an IV set spike (314), a tip (315), and a trailing edge (319). The limiting part (318) may be arranged adjacent to the tip (315). For example, the limiting part (318) may be arranged distally with respect to the midpoint of the IV set spike (314). The trailing edge (319) may include a plurality of barbs. The IV set spike (314) may include an abutment flange (317). An alternating flange (317) may be positioned between the tip (315) and the limiting portion (318). The alternating flange (317) may limit the movement of the limiting portion (318) toward the tip (315) to prevent the limiting portion (318) from sliding away from the IV set spike (314) when a removal force, such as the force F1 shown in FIG. 1 described above, is applied to the IV set spike (314). In an embodiment, the first connector (310) may be provided without ribs. Alternatively, the first connector (310) may include any number of ribs.

[0034] FIG. 5 illustrates a perspective view of a first connector (410). Except for mutually exclusive features, the first connector (410) may include any or all of the features previously described with reference to the first connector (210, 310) where similar parts correspond to similar parts, and vice versa. The first connector (410) may include, for example, an opposing part (412), a flange (413), an IV set spike (414), a tip (415), one or more ribs (416), and a limiting part (418) having a trailing edge (419). In an embodiment, the ribs (416) and / or the limiting part (418) may be formed integrally with the IV set spike (414). In an embodiment, the first connector (410) may include five ribs (416), but a different number of ribs is possible, or there may be no ribs at all. One or more of the limiting portion (418) and rib (416) may be provided proximal to the midpoint of the IV set spike (414).

[0035] FIG. 6 illustrates a cross-sectional view of a first connector (510) placed within a port (12). Except for mutually exclusive features, the first connector (510) may include any or all of the previously described features with reference to the first connectors (210, 310, 410) corresponding to similar parts, and vice versa. For example, the first connector (510) may include a limiting part (518) having an opposing part (512), a flange (not shown), an IV set spike (514), a tip (515), and a trailing edge (519). The limiting part (518) may be harpoon-shaped. The trailing edge (519) may be hooked to the inner membrane of the port (12) to secure the IV set spike (514) to the port (12). In the embodiments, the first connector (510) may be provided without ribs. Alternatively, the first connector (510) may include any number of ribs.

[0036] FIGS. 7 through 9 illustrate a first connector (610) having a limiting portion (619). Except for mutually exclusive features, the first connector (610) may include any one or all of the previously described features with reference to the first connector (210, 310, 410, 510) where similar parts correspond to similar parts, and vice versa. The limiting portion (619) may be provided as an alternative or additional (i.e., as a second limiting portion) to any of the previously described limiting portion embodiments. That is, the limiting portion (619) may be used as an alternative or additional limiting portion in conjunction with any of the first connector (110, 210, 310, 410, 510) embodiments.

[0037] The limiting portion (619) may be detachably connected to the first connector (610). For example, the limiting portion (619) may slide on the first connector (610) proximal to the flange (613) of the first connector (610). The limiting portion (619) may include one or more arms (650) that can extend along the longitudinal direction of the first connector (610). In an embodiment as illustrated in FIGS. 7 through 9, the limiting portion (619) may include two arms (650), but other combinations of arms (650) are also possible. Each arm (650) may include one or more teeth (652). In an embodiment as illustrated in FIGS. 7 through 9, each arm (650) may include four teeth (652), but other combinations of teeth (652) are possible. The teeth (652) may extend at an angle from an individual arm (650) toward the proximal end of the limiting portion (619). According to this configuration, when the first connector (610) is inserted into the port (12) without obstruction of insertion, the teeth (652) [attach] the port (12) of the IV bag (10) It can be slid along. Additionally, to resist separation of the port (12) and the first connector (610), the tooth (652) can grip the outer surface of the port (12) after the first connector (610) is inserted into the port (12). As shown in FIG. 8, the tooth (652) can grip the rigid port (12a) including the flange proximal to the rigid port (12a). As shown in FIG. 9, the tooth (652) can grip the flexible port (12b).

[0038] FIGS. 10 through 18 illustrate embodiments of second connectors (220, 320, 420, 520, 620). Except for mutually exclusive features, embodiments of second connectors (220, 320, 420, 520, 620) may include any of the features described above with reference to the second connector (120), such that similar parts correspond to similar parts, and vice versa. Additionally, any one of the second connectors (220, 320, 420, 520, 620) may be used in the system (1) and may be provided as part of the fitting (100) in the same manner as described above with reference to the second connector (120).

[0039] FIGS. 10 and FIGS. 11 illustrate an embodiment of a second connector (220). The second connector (220) may form a connection B with the IV set spike (22) of the injection set (20). The second connector (220) may include a port (224) having an opening (226) for receiving the IV set spike (22). The port (224) may include a recess (228) capable of holding the opposing portion (222). The recess (228) may be conical and may tapere downward toward the opening (226). For example, as shown in FIG. 10, the recess (228) may have a first inner diameter (201) at the innermost part of the recess (228) relative to the opening (226), and a second inner diameter (202) at the outermost part of the recess (228) relative to the opening (226). The first inner diameter (201) may be larger than the second inner diameter (202), and the recess (228) may taper along the first height h1 of the recess (228) from the first inner diameter (201) to the second inner diameter (202). The recess (228) may taper continuously or discontinuously.

[0040] As illustrated in FIG. 10, the second connector (220) may include an opposing portion (222) retained within a recess (228). The opposing portion (222) may include a locking ring (223) retained within the recess (228). FIG. 11 illustrates a perspective view of the locking ring (223) illustrated in FIG. 10. The locking ring (223) may include an inner circumferential ridge (225). The inner circumferential ridge (225) may have a third inner diameter (203) capable of gripping the IV set spike (22) to resist removal of the IV set spike (22) from the port (224). The locking ring (223) may have a second height h2. The locking ring (223) may include a longitudinal slit (227). The locking ring (223) may be manufactured from any suitable material, for example, plastic and / or metal. The locking ring (223) may include a taper complementary to the taper of the recess (228) so that the locking ring (223) can be firmly fitted into the recess (228). For example, the locking ring (223) may be formed in a conical shape.

[0041] In an embodiment, the second height h2 of the locking ring (223) may be smaller than the first height h1 of the recess (228), so that the recess (228) can accommodate the translation of the locking ring (223) within the recess (228). The locking ring (223) may initially be positioned adjacent to the narrowest area of ​​the recess (228), i.e., the second inner diameter (202). The third inner diameter (203) of the locking ring (223) is variable. When the IV set spike (22) is inserted into the port (224), the locking ring (223) may be further translated into the interior of the port (224) within the recess (228) and may be adjacent to the widest area of ​​the recess (228), i.e., the first inner diameter (201). As the locking ring (223) translates within the recess (228), the longitudinal slit (227) may allow the locking ring (223) to expand within the recess (228), that is, to increase the third inner diameter (203) to accommodate the insertion of the IV set spike (22). Upon application of a removal force (e.g., the second force F2 described above) attempting to separate connection B, the third inner diameter (203) may be reduced so that the third inner diameter (203) is smaller than the outer diameter of the IV set spike (22). For example, the third inner diameter (203) may be reduced to at least 4.5 mm (+ / - 10%) in the narrowest part of the recess (228). Since the third inner diameter (203) can be reduced so that the third inner diameter (203) is smaller than the outer diameter (i.e., 5 mm) of the IV set spike (22), the locking ring (223) can grip the IV set spike (22) through the inner circumferential ridge (225).

[0042] FIGS. 12 and FIGS. 13 illustrate exploded and cross-sectional views of the second connector (320), respectively. Except for mutually exclusive features, the second connector (320) may include any or all of the previously described features with reference to the second connector (220) where similar parts correspond to similar parts, and vice versa. For example, the second connector (320) may include a port (324) having an opening (326) for receiving an IV set spike (22). The port (324) may include a recess (328) capable of holding an opposing part (322). The opposing part (322) may include a locking ring (323) held within the recess (328). The locking ring (323) may hold the IV set spike (22) to resist removal of the IV set spike (22) from the port (324).

[0043] The locking ring (323) may be disc-shaped and may have an inner diameter (305) and an outer diameter (306). The inner diameter (305) may be sized to accommodate the insertion of the IV set spike (22). The outer diameter (306) may be sized to fit the opening (326). The locking ring (323) may have a topside (329) and a bottom side (370). In an embodiment, the topside (329) has a top projection (372) that is substantially perpendicular to the plane defined by the topside (329). The bottom side (370) may include a bottom projection (374) that is substantially perpendicular to the plane of the bottom side (370), opposite the top projection (372), and positioned at 180° on the opposite portion of the locking ring (323). The lower projection (374) and the upper projection (372) may have different lengths. For example, in the embodiment illustrated in FIG. 12 and FIG. 13, the lower projection (374) may be longer than the upper projection (372).

[0044] A locking ring (323) may be positioned inside a first holder (340) having an inner diameter (307) sized to accommodate the outer diameter (306) of the locking ring (323). A second holder (342) may have an outer diameter (308) sized to fit the inner diameter (307) of the first holder (340). The second holder (342) may be positioned at the top (i.e., distal) of the locking ring (323) within the first holder (340). In an embodiment, the first holder (340) may include a guard rail on the outer surface of the main body.

[0045] The second holder (342) may have an inner diameter (309) larger than the outer diameter of the IV set spike (22). When the IV set spike (22) is inserted into the port (324), the locking ring (323) is angled so that the lower projection (374) contacts the inner bottom surface (376) of the first holder (340) and the upper projection (372) contacts the bottom edge (378) of the second holder (342). Since the lower projection (374) may be longer than the upper projection (372), the locking ring (323) is angled and wedges the IV set spike (22) to a position that restricts axial movement of the IV set spike (22) so as to hold the IV set spike (22) inserted at the inner edge of the locking ring (323) adjacent to the lower projection (374) and at the inner edge adjacent to the upper projection (372) of the locking ring (323).

[0046] FIGS. 14 through 16 illustrate cross-sectional views of a second connector (420). Except for mutually exclusive features, the second connector (420) may include any or all of the previously described features with reference to the second connector (220, 320) where similar parts correspond to similar parts, and vice versa. The second connector (420) may include a port (424) defined within the first holder (440) and the second holder (442). The port (424) may include an opening (426) for receiving an IV set spike (22). The port (424) may include a recess (428) capable of holding an opposing part (422). The opposing part (422) may include a locking ring (423) and a spring (444) held within the recess (428). The spring (444) can apply force to the locking ring (423), and the locking ring (423) can resist removing the IV set spike (22) from the port (424) by gripping the IV set spike (22).

[0047] In an embodiment, the locking ring (423) may be flat and may be located within the recess (428) of the second connector (420). The inner diameter (402) of the opening (426) may be smaller than the inner diameter (401) of the recess (428). The second connector (420) may have an inner step (437) protruding into the recess (428). In an embodiment, the inner step (437) does not extend beyond 25% of the circumference of the inner wall of the second connector (420). In an embodiment, the locking ring (423) has an outer circumference that is 10% or less smaller than the circumference of the inner wall of the second connector (420). The locking ring (423) may have an inner circumference opening capable of receiving the IV set spike (22). A spring (444) may be located at the top of the locking ring (423) within the recess (428).

[0048] When the IV set spike (22) is inserted into the second connector (420) through the locking ring (423), axial movement from the second connector (420) can be locked again by the locking ring (423). This can occur when the locking ring (423) is pressed at a certain angle by the spring (444) against the inner step (437) and the inner bottom of the holder. In this way, the inner atom of the opening of the locking ring (423) is pressed against the IV set spike (22) and wedges against the IV set spike (22), thereby maintaining the IV set spike (22) at an angle adjusted to restrict axial movement.

[0049] FIG. 17 illustrates a cross-sectional view of a second connector (520). Except for mutually exclusive features, the second connector (520) may include any or all of the previously described features with reference to the second connector (220, 320, 420) where similar parts correspond to similar parts, and vice versa. The second connector (520) may include a port (524) defined within the first holder (540) and the second holder (542). The port (524) may include an opening (526) for receiving an IV set spike (22). The port (524) may include a recess (528) capable of holding an opposing part (522). The opposing part (522) may include a locking ring (523) and a spring (544) held within the recess (528). The spring (544) can apply force to the locking ring (523), and the locking ring (523) can resist removing the IV set spike (22) from the port (524) by gripping the IV set spike (22). The first holder (540) may include a first connector (554), and the second holder (542) may include a second connector (556). The first connector (554) and the second connector (556) are complementary to each other and can connect the first holder (540) and the second holder (542) together. In an embodiment, the first connector (554) and the second connector (556) may be snap fittings, threads, or other known connectors.

[0050] FIG. 18 illustrates a cross-sectional view of a second connector (620). Except for mutually exclusive features, the second connector (520) may include any or all of the previously described features by reference to the second connector (220, 320, 420, 520) where similar parts correspond to similar parts, and vice versa. The second connector (620) may include a first holder (640) and a second holder (642). The first holder (640) may include a first stopper (658), and the second holder (642) may include a second stopper (660). The first stopper (658) and the second stopper (660) may be complementary and may be engaged together to prevent the first holder (640) and the second holder (642) from rotating relative to each other around the longitudinal axis of the second connector (620). The first stopper (658) and the second stopper (660) may be configured and arranged so that the first holder (640) can slide into the second holder (642) along the longitudinal axis of the second connector (620) without interference from the first stopper (658) and the second stopper (660). In an embodiment, the first stopper (658) and the second stopper (660) may be grooves, protrusions, and combinations thereof.

[0051] FIGS. 19 and 20 illustrate embodiments of a third connector (230, 330). Except for mutually exclusive features, embodiments of the third connector (230, 330) may include any of the features described above with reference to the third connector (130), such that similar parts correspond to similar parts, and vice versa. Additionally, any one of the third connectors (230, 330) may be used in the system (1) and may be provided as part of the fitting (100) in the same manner as previously described with reference to the third connector (130).

[0052] FIG. 19 illustrates a cross-sectional view of a third connector (230) that can form a connection C with a male lure (32). The third connector (230) may include a female lure (231). The female lure (231) may include a thread that may be complementary to the thread included in the male lure (32). Thus, the male lure (32) may be threaded to the female lure (231). The opposing portion (232) may be a ring (233). The ring (233) may include a protrusion (234), such as a fin or ratchet, having at least one angled tooth. The protrusion (234) may be arranged in a circumferential thread. The protrusion (234) may be flexible in one direction (e.g., the closing direction) and rigid in the other direction (e.g., the opening direction). According to this configuration, the protrusion (234) can be bent so that the locking nut of the male lure (32) can be threaded onto the female lure (231). The protrusion (234) can be molded or crimped. Once threaded, the protrusion (234) can resist removal of the locking nut of the male lure (32) due to the rigidity of the protrusion (234) in the opening direction of the locking nut of the male lure (32).

[0053] FIG. 20 illustrates a cross-sectional view of a third connector (330). Except for mutually exclusive features, the third connector (330) may include any or all of the features previously described by reference to the third connector (230) where similar parts correspond to similar parts, and vice versa. For example, the third connector (330) may include a female lure (331). A male lure (32) may be threaded onto the female lure (331). The third connector (330) may include an opposing part (332) which may be a ring (333). The ring (333) may include a protrusion (334), such as a pin or ratchet having at least one angled tooth, as previously discussed. The third connector (330) may include a guard (362). The guard (362) may surround part or all of the opposing part (332). The guard (362) can protect against fingers getting caught or interfering with the connection between the third connector (330) and the water lure (32).

[0054] FIGS. 21 and 22 illustrate embodiments of fittings (200, 300). Except for mutually exclusive features, embodiments of fittings (200, 300) may include any of the aforementioned features by reference to fittings (100) corresponding to similar parts, and vice versa. Additionally, any of fittings (200, 300) may be used in the system (1). FIG. 21 illustrates a view of fitting (200). Fitting (200) may include a first connector (210), a second connector (220), and a third connector (230).

[0055] FIG. 22 illustrates a view of a fitting (300). The fitting (300) may include a first connector (410), a second connector (420), and a third connector (330). The fitting (300) may include a body (302) that defines a grip to help a user grasp the fitting (300). In an embodiment, any of the aforementioned fittings (100, 200) may include a similar body that defines a grip.

[0056] FIGS. 23 and 24 illustrate a device (1000) for closed sterile delivery (CST). The device (1000) may include an outer body (1002). In an embodiment, the outer body (1002) of the device (1000) may be connected to any one of the third connectors (130, 230, 330) to form a connection C and may include a connector (e.g., a Luer lock connector) capable of providing a CST of a drug from a drug source (30). Additionally or alternatively, the device (1000) may provide a CST of a drug from the drug source (30) to any number of other devices, including syringes, among other possible ones. The outer body may define an inner (1004). The outer body (1002) may include a channel (1006) that can be extended through the outer body and opened from the opening (1007) to the inside (1004). The device (1000) may include a diaphragm (1008). The diaphragm (1008) may seal the channel (1006) of the outer body (1002). In an embodiment, the diaphragm (1008) may be divided or perforated by a syringe during the CST of the drug from the drug source (30).

[0057] The device (1000) may include an inner body (1010) that can be contained within the interior (1004) of an outer body (1002). The inner body (1010) may define an interior (1012). The inner body (1010) may include a sealing portion (1014) within the interior (1012) of the inner body (1010). The sealing portion (1014) may fluidly seal an opening (34) of a drug source (30) (e.g., a container, a vial, etc.). The inner body (1010) may include a projection (1016). The projection (1016) may extend through the sealing portion (1014). The projection (1016) may include a first channel (1018) that fluidly connects the channel (1006) of the outer body (1002) and the interior (1012) of the inner body (1010). The projection (1016) may include a second channel (1020) that fluidly connects the interior (1004) of the outer body (1002) and the interior (1012) of the inner body (1010). In an embodiment, the first channel (1018) may be used to extract a drug from a drug source (30), and the second channel (1020) may be part of a path P that can serve as a vent for gas (e.g., air) during the extraction of the drug.

[0058] The inner body (1010) may also include a filter (1022). The filter (1022) may extend circumferentially around the central axis of the inner body (1010) and may be arranged in the interior (1004) of the outer body (1002) when the inner body (1010) is assembled together with the outer body (1002). According to this configuration, the filter (1022) may filter gas or other substances flowing out from the interior of the drug source (30) (e.g., through path P) and may provide CST. Since the filter (1022) can be arranged circumferentially around the central axis of the internal body (1010), the device (1000) can have a compact form factor, which can, for example, improve the storage and availability of the device (1000) and improve disposability because the device (1000) occupies less space than when the filter is provided externally.

[0059] In an embodiment, the filter (1022) may include a hydrophobic medium, which may reduce or prevent fluid from passing through the filter (1022). In an embodiment, the filter (1022) may be charged (as a charge-based coating), which may attract and filter complementarily charged particles. In an embodiment, the filter (1022) may include pores. For example, the pore size may be 0.2 μm or less. In an embodiment, the filter (1022) may include a material that inhibits biological attachment and / or proliferation, for example, PTFE, among other possible materials. In an embodiment, the filter (1022) may be pleated, which may increase the surface area of ​​the filter (1022) and improve filtration. In the embodiment, the filter (1022) may have a restoring force and may apply force to the sealing part (1014) to fluidly seal the opening (34) of the drug supply source (30).

[0060] As illustrated in FIG. 24, the inner body (1010) and the outer body (1002) together can define a path P through which gas escapes from the interior (1012) of the inner body (1010). Path P can extend outward through a second channel (1020) of the inner body (1010), through the interior (1004) of the outer body (1002), through a filter (1022), and through an outlet (1024) of the device. According to this configuration, the filter (1022) can reduce or prevent leakage of the drug and / or vapor from the drug source (30) and can provide a CST of the drug / other substance from the drug source (30). Because the filter (1022) is arranged internally (e.g., circumferentially around the inner body (1010)), the gas can be routed internally and the overall form factor of the device (1000) can be improved.

[0061] In an embodiment, the drug source (30) may include a plastic material forming an opening (34). The plastic material may include, for example, a cyclic olefin polymer and / or a cyclic olefin copolymer. The device (1000) may be connected to a drug source (30) including an embodiment of the drug source (30) including a plastic material forming an opening (34) in a manner that allows CST of the drug within the drug source (30). The device (1000) may also include plastic, such as a cyclic olefin polymer and / or a cyclic olefin copolymer, but other additional or alternative materials are also possible.

[0062] For example, the device (1000) may include a connector (1026) that can be connected to an opening (34) of a drug source (30) and enable the CST of a substance from the drug source (30). In an embodiment, the connector (1026) may be pressurized over the opening (34) of the drug source (30). In an embodiment, the connector (1026) may be screw-coupled to the opening of the drug source (30). The connector (1026) of the device (1000) may include, for example, a first locking part (1028) and a second locking part (1030). The first locking part (1028) and the second locking part (1030) may be complementary to the connector of the opening (34) (e.g., a flange, a nub, a tap, a ridge, etc.) for connecting to the opening (34). In an embodiment, the seal (1014) may be elastic and may form a component of the connector (1026). In an embodiment, the filter (1022) may be elastic and may form a component of the connector (1026). Additionally or alternatively, the filter (1022) may include a separate structure (e.g., a ring) that can be overmolded to apply force to the opening (34) to seal the opening (34).

[0063] In an embodiment, the device (1000) may include a cap (1032). The cap (1032) may be removablely connected to an outer body (1002) to cover a diaphragm (1008).

[0064] It will be understood that the foregoing description provides examples of the invention. However, other embodiments of the invention may differ in detail from the foregoing examples. All references to the invention or examples thereof are intended to refer to the specific examples discussed at that time and, more generally, do not imply any limitation to the scope of the invention. Any language of distinction or disparagement regarding specific features is intended to indicate a lack of preference for such features, and is not intended to completely exclude such features from the scope of the invention unless otherwise stated.

Claims

Claim 1 A closed-system liquid delivery device configured for use with each of an infusion container having a port for administering said infusion, a medicinal source having a male Luer having a medicinal substance, and an infusion set including an IV set spike, wherein the closed-system liquid delivery device comprises: a main body; an IV set spike at a first end of the main body configured to be fluidically connected to said port of said infusion container; a port at a second end of the main body configured to seal and receive said IV set spike of said infusion set; a locking ring received in said port of the closed-system liquid delivery device - said locking ring configured to resist a force removing said IV set spike of said infusion set from said port of the closed-system liquid delivery device - A closed-system liquid delivery device comprising: a female lure at a third end of the main body configured to be fluidly connected to the male lure of the above-mentioned drug source; a first lumen fluidly connecting the opening of the female lure and the opening positioned at the first distal of the IV set spike - the first lumen is configured to provide fluid communication from the drug source through the female lure to an injection container separated from the port of the closed-system liquid delivery device -; and a second lumen fluidly connecting the port of the closed-system liquid delivery device to the opening positioned at the second distal of the IV set spike - the second lumen is configured to provide fluid communication from the injection container to the port of the closed-system liquid delivery device containing a liquid received from the drug source through the first lumen -; Claim 2 A closed-system liquid delivery device according to claim 1, wherein the locking ring is configured to translate or rotate to resist the force removing the IV set spike of the injection set from the port of the closed-system liquid delivery device. Claim 3 A closed-system liquid delivery device according to claim 1, wherein the locking ring has a plurality of circumferential ridges on the inner surface of the locking ring, and the locking ring is provided within the recess of the port of the closed-system liquid delivery device. Claim 4 A closed-type system liquid delivery device according to claim 3, wherein the recess is tapered, and the translational movement of the locking ring toward the narrow portion of the recess reduces the diameter of the locking ring. Claim 5 A closed-type system liquid delivery device according to any one of claims 1 to 4, wherein the female lure comprises a plurality of protrusions configured to resist rotation in the opening direction of the male lure. Claim 6 A closed-system liquid delivery device according to any one of claims 1 to 4, wherein the IV set spike of the closed-system liquid delivery device comprises a restrainer having an outwardly protruding trailing edge defining a plurality of barbs. Claim 7 In claim 6, the IV set spike of the closed-system liquid delivery device comprises: a tip; and one or more ribs between the tip and the limiting portion, the closed-system liquid delivery device. Claim 8 In claim 6, the IV set spike of the closed-system liquid delivery device comprises an abutment, and the opposite end of the limiting portion to the outwardly protruding trailing edge is adjacent to the abutment, the closed-system liquid delivery device. Claim 9 A closed-type system liquid delivery device according to any one of claims 1 to 4, wherein the locking ring has an upper side and a lower side, the upper side has an upper projection perpendicular to the plane of the upper side, and the lower side has a lower projection perpendicular to the plane of the lower side and in a 180° direction opposite to the upper projection and in a portion opposite to the locking ring. Claim 10 A closed-type system liquid delivery device according to any one of claims 1 to 4, wherein the locking ring is flat and is positioned within a holder having an opening sized to accommodate the insertion of the IV set spike of the injection set at its lower end, the holder having an inner wall and an inner step, the inner wall having a diameter larger than the diameter of the opening, the inner step being between the opening and the inner wall, the locking ring being on the upper end of the inner step, and a spring being on the upper end of the locking ring. Claim 11 A closed-type system liquid delivery device according to claim 10, wherein the inner step does not extend more than 25% of the circumference of the inner wall and the locking ring has an outer circumference that is 10% or less smaller than the circumference of the inner wall. Claim 12 A closed-type system liquid delivery device according to claim 10, wherein the holder is a first holder, and the closed-type system liquid delivery device further comprises a second holder accommodated within the first holder, wherein the first holder comprises a first connector, and the second holder comprises a second connector complementary to the first connector and configured to be connected to the first connector to connect the first holder and the second holder. Claim 13 A closed-type system liquid delivery device according to claim 12, wherein the first holder comprises a first stopper and the second holder comprises a second stopper that is complementary to the first stopper and configured to engage with the first stopper to prevent relative rotation between the first holder and the second holder. Claim 14 A closed-system liquid delivery device according to any one of claims 1 to 4, wherein the IV set spike of the closed-system liquid delivery device comprises an arm defining a tooth configured to grip the port of the injection fluid container. Claim 15 A kit comprising: a closed-system liquid delivery device according to any one of claims 1 to 4; an infusion fluid container, a drug source; and an infusion set. Claim 16 In item 15, the above-mentioned drug source is a kit including a syringe. Claim 17 A closed-system liquid delivery device according to any one of claims 1 to 4, wherein the force is at least 15N. Claim 18 A closed-system liquid delivery device according to claim 13, wherein the force is at least 30 N. Claim 19 A closed-system liquid delivery device configured for use with each of an infusion container having a port for administering said infusion, a drug source having a male lure having a drug source having a male lure, and an infusion set including an IV set spike, wherein the closed-system liquid delivery device comprises: a main body; an IV set spike at a first end of the main body configured to be fluidically connected to said port of said infusion container; a port at a second end configured to seal and receive said IV set spike of said infusion set; and a female lure at a third end of the main body configured to be fluidly connected to said male lure of said drug source—said female lure comprising a plurality of protrusions configured to resist rotation of said male lure in an open direction. Claim 20 In claim 19, the above-mentioned plurality of protrusions are arranged in circumferential threads, a closed-type system liquid delivery device. Claim 21 A closed-system liquid delivery device according to claim 19 or 20, wherein the IV set spike of the closed-system liquid delivery device comprises a limiting portion having an outwardly protruding trailing edge defining a plurality of barbs. Claim 22 In claim 21, the IV set spike of the closed-system liquid delivery device comprises: a tip; and one or more ribs between the tip and the limiting portion, the closed-system liquid delivery device. Claim 23 In claim 21, the IV set spike of the closed-system liquid delivery device comprises an alternation, and the opposite end of the limiting portion to the outwardly protruding trailing edge is adjacent to the alternation, the closed-system liquid delivery device. Claim 24 A closed-system liquid delivery device according to claim 19 or 20, further comprising: a first lumen fluidly connecting the opening of the female lure and the opening positioned at the first distal of the IV set spike of the closed-system liquid delivery device—the first lumen is configured to provide fluid communication from the drug source through the female lure to an injection container separated from the port of the closed-system liquid delivery device; and a second lumen fluidly connecting the port of the closed-system liquid delivery device to the opening positioned at the second distal of the IV set spike of the closed-system liquid delivery device—the second lumen is configured to provide fluid communication from the injection container to the port of the closed-system liquid delivery device containing a liquid received from the drug source through the first lumen. Claim 25 A kit comprising: a closed-system liquid delivery device of claim 19 or 20; an infusion fluid container; a drug source; and an infusion set. Claim 26 In paragraph 25, the above-mentioned drug source is a kit including a syringe. Claim 27 delete Claim 28 delete Claim 29 delete Claim 30 delete Claim 31 delete Claim 32 delete Claim 33 delete Claim 34 delete Claim 35 delete Claim 36 delete Claim 37 delete Claim 38 delete Claim 39 delete Claim 40 delete Claim 41 delete Claim 42 delete Claim 43 delete Claim 44 delete Claim 45 delete Claim 46 delete Claim 47 delete

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