CN117460488A

CN117460488A - Closed system delivery device

Info

Publication number: CN117460488A
Application number: CN202280038652.7A
Authority: CN
Inventors: 卡尔-马丁·伯格; 弗洛林·科普; 乌韦·埃里克·施奈德; 瓦拉布拉德·锡基勒; 克里斯蒂安·沃尔特; 布鲁斯·W·布鲁内蒂; 斯科特·艾伦·莫耶; 加里·希金斯; 詹姆斯·艾伯特·尼克松; 尼古拉斯·潘尼克
Original assignee: B Braun Melsungen AG; B Brian Medical Ltd
Current assignee: B Braun Melsungen AG; B Brian Medical Ltd
Priority date: 2021-04-29
Filing date: 2022-04-28
Publication date: 2024-01-26

Abstract

A closure system delivery device includes a first adapter and a second adapter connected to each other in a coupled state to form a sealed fluid passageway between two reservoirs. The first adapter may be attached to a first reservoir and the second adapter may be attached to a second reservoir. One or both adapters may include a membrane that engages the other membrane during coupling and uncoupling to prevent the release of liquid or vapor into the environment. The device may further comprise a vent line equalizing the pressure between the two reservoirs. The ventilation line may comprise at least one filter to filter the gases in the device. In addition, or in the alternative, the vent line may be connected in fluid communication with an inflatable membrane that stores gas within the device and helps equalize pressure.

Description

Closed system delivery device

Karl-Martin Berg

Bruce W.Brunetti

Gary Higgins

Florin Kopp

Scott Alan Moyer

James Albert Nixon

Nicholas Panick

Uwe Erik Schneider

Varaprasad Sikhile

Christian Walter

Technical Field

The present disclosure relates to a device for safely delivering a hazardous drug between containers in a closed system that prevents contaminants from flowing into the system and prevents hazardous vapors from being released from the system into the environment.

Cross reference to related applications

The present application requests priority from: U.S. provisional application No. 63/181,313 filed on 29 th year 2021, U.S. provisional application No. 63/181,387 filed on 29 th year 2021, U.S. provisional application No. 63/181,429 filed on 29 th year 2021, U.S. provisional application No. 63/181,446 filed on 29 th year 2021, U.S. provisional application No. 63/181,457 filed on 29 th year 2021, U.S. provisional application No. 63/196,735 filed on 29 th year 2021, and U.S. provisional application No. 6/month 2021. The contents of all of the foregoing applications are incorporated by reference herein in their entirety and for all purposes.

Background

A closed system delivery device (CSTD) is a system for delivering a drug from one reservoir or container (e.g., a syringe) to another reservoir or container (e.g., a vial) while limiting the possibility of drug aerosolization, drug contamination, sharps exposure, and harmful drug exposure. Once connected between the reservoirs, the CSTD device equalizes the pressure gradient between the reservoirs. Without the pressure equalization system, the pressure differential can result in the generation of fine aerosols that escape into the atmosphere and expose the environment, patient and health care professional to harmful medications.

Disclosure of Invention

A closure system delivery device includes a first adapter and a second adapter connected to each other in a coupled state to form a sealed fluid passageway between two reservoirs.

In one aspect of the present disclosure, a closure system delivery device includes a first adapter attachable to a first reservoir. The first adapter may define a first channel and have a first septum sealing an end of the first channel. The device may also have a second adapter configured to attach to the second reservoir. The second adapter may include a housing having an interior and defining a second passage. The second diaphragm may seal an end of the second channel.

In another aspect of the disclosure, the device may include a carrier that is movable within the second adapter. The carrier may define a chamber containing at least a portion of the second membrane. A needle having a needle opening may be disposed inside the second adapter.

In another aspect of the disclosure, the interior of the second adapter may be adapted to receive the first adapter in a telescoping manner, wherein the first adapter is insertable into the second adapter.

In another aspect of the disclosure, the carrier may be displaceable in the interior of the second adapter relative to the needle by the first adapter when the first adapter is inserted into the second adapter.

In another aspect of the disclosure, the carrier may be displaceable within the second adapter between a first position in which the first septum abuts the second septum and the needle opening is sealed within the second channel, and a second position in which the first septum abuts the second septum and the needle opening is in fluid communication with the first channel to connect the first adapter and the second adapter in the fluid path open state.

In another aspect of the disclosure, the device may include a releasable lock that locks the first adapter within the second adapter after insertion of the first adapter into the second adapter.

In another aspect of the disclosure, the releasable lock may lock the first adapter within the second adapter when the carrier is displaced to the second position.

In another aspect of the present disclosure, the releasable lock may include a first locking element located on the carrier and a second locking element located in the housing.

In another aspect of the disclosure, the releasable lock may include a first locking element located on the first adapter and a second locking element located in the second adapter.

In another aspect of the present disclosure, the releasable lock may be released by pressing at least one side of the housing radially inward.

In another aspect of the present disclosure, at least one side of the housing may include at least one button.

In another aspect of the disclosure, at least one button may be pressed radially inward to disengage a portion of the carrier from a section of the housing.

In another aspect of the disclosure, the portion of the carrier may include at least one locking lug and the section of the housing may include at least one locking ramp inside the housing.

In another aspect of the disclosure, at least one button may be pressed radially inward to disengage a portion of the first adapter from a section of the second adapter.

In another aspect of the disclosure, the portion of the first adapter may include at least one flange and the section of the second adapter may include at least one securing clip attached to the at least one button.

In another aspect of the disclosure, the releasable lock may be released by rotating the second adapter relative to the first adapter.

In another aspect of the disclosure, the second adapter may include a third diaphragm axially spaced from the second diaphragm.

In another aspect of the present disclosure, the needle opening may be sealed between the second septum and the third septum when the carrier is in the first position.

In another aspect of the disclosure, the second diaphragm may include a piston having a piston head and a collapsible midsection at least partially contained in a carrier.

In another aspect of the disclosure, the collapsible middle section of the piston may define a hollow core, and the needle may be at least partially contained within the hollow core.

In another aspect of the disclosure, the device may include a female luer connector rotatably mounted to the housing of the second adapter.

In another aspect of the disclosure, the female luer connector may include threads that may mate with a threaded connection on the second reservoir.

In another aspect of the disclosure, the first adapter may comprise a female luer connector.

In another aspect of the present disclosure, the first adapter may comprise a vial spike.

In another aspect of the disclosure, the first adapter and the second adapter may be rectangular.

In another aspect of the disclosure, the first adapter and the second adapter may be cylindrical.

In another aspect of the present disclosure, the needle may be secured inside the second adapter.

In another aspect of the disclosure, the releasable lock may include a first locking element on the carrier and a second locking element on the first adapter.

In another aspect of the disclosure, the section of the carrier may include at least one locking hole and a portion of the housing may include at least one detent.

In another aspect of the present disclosure, the releasable lock may include a locking arm that extends through a slot in a wall of the housing.

In another aspect of the present disclosure, the locking arm may be pivotally mounted in a slot on at least one hinge.

In another aspect of the present disclosure, the locking arm may be pivotally mounted in a slot between a locked position locking the first adapter within the second adapter and a released position allowing the first adapter to be removed from the second adapter.

In another aspect of the present disclosure, the locking arm includes a first end that protrudes radially outward from the wall of the housing when the locking arm is in the locked position.

In another aspect of the present disclosure, the first end of the locking arm may include a button.

In another aspect of the present disclosure, the locking arm includes a second end that protrudes radially inward from the wall of the housing when the locking arm is in the locked position.

In another aspect of the present disclosure, the second end may include a pawl that engages the carrier when the locking arm is in the locked position.

In another aspect of the present disclosure, the pawl may include a beveled surface and an abutment surface.

In another aspect of the present disclosure, the carrier may include a locking aperture adapted to receive the pawl when the carrier is in the second position and when the locking arm is in the locked position.

In another aspect of the present disclosure, the locking aperture may include an abutment edge that engages an abutment surface of the pawl when the carrier is in the second position and when the locking arm is in the locked position to prevent the carrier from moving out of the second position.

In another aspect of the present disclosure, a closure system delivery device includes a first adapter configured to attach to a first reservoir. The first adapter may define a first channel and have a first septum sealing an end of the first channel. The device may also have a second adapter configured to attach to the second reservoir. The second adapter may include a housing having an interior and defining a second passage. The second diaphragm may seal an end of the second channel.

In another aspect of the disclosure, the device may include a carrier that is movable within the second adapter. The carrier may define a chamber containing at least a portion of the second membrane. A needle having a needle opening may be secured inside the second adapter.

In another aspect of the disclosure, the interior of the first adapter may be adapted to receive the second adapter in a telescoping manner.

In another aspect of the disclosure, the carrier may be displaceable in the interior of the second adapter relative to the needle through the interior of the first adapter when the second adapter is inserted into the first adapter.

In another aspect of the disclosure, the device may include a releasable lock that locks the second adapter within the first adapter after insertion of the second adapter into the first adapter.

In another aspect of the disclosure, the releasable lock may lock the second adapter within the second adapter when the carrier is displaced to the second position.

In another aspect of the present disclosure, the releasable lock may be released by pressing one side of the first adapter radially inward.

In another aspect of the disclosure, the side of the first adapter may include a button.

In another aspect of the present disclosure, the button may be pressed radially inward to disengage a portion of the first adapter from the section of the housing.

In another aspect of the disclosure, the portion of the first adapter may include at least one locking aperture and the section of the housing may include at least one locking ramp extending radially outwardly from the housing.

In another aspect of the present disclosure, the at least one locking ramp includes a leading end, a trailing end, and a ramp surface between the leading end and the trailing end.

In another aspect of the present disclosure, an abutment surface in the at least one locking hole may engage a trailing end of the at least one locking ramp to lock the second adapter to the first adapter.

In another aspect of the present disclosure, the ramp surface may include a straight section adjacent the leading end, and a curved section extending between the straight section and the trailing end.

In another aspect of the present disclosure, the curved section may have a compound curvature defining a concave portion and a convex portion.

In another aspect of the present disclosure, the releasable lock may include a locking arm that extends through a slot in a wall of the first adapter.

In another aspect of the present disclosure, the locking arm may be pivotally mounted in a slot between a locked position locking the second adapter within the first adapter and a released position allowing the second adapter to be removed from the first adapter.

In another aspect of the disclosure, the first end may include a button.

In another aspect of the present disclosure, the locking arm may include a second end that is positioned in the slot when the locking arm is in the locked position.

In another aspect of the present disclosure, the second end may include an abutment surface that engages the housing when the locking arm is in the locked position.

In another aspect of the present disclosure, a vial spike may include a housing and a spike connector extending from the housing.

In another aspect of the present disclosure, the housing and spike connector can define a vent line and a transfer line separate from the vent line.

In another aspect of the disclosure, the vent line may include a hydrophobic filter in the housing.

In another aspect of the disclosure, the vent line may include an activated carbon filter in series with the hydrophobic filter.

In another aspect of the disclosure, the housing may include a first housing portion having a dry break coupler in fluid connection with the delivery line.

In another aspect of the present disclosure, the dry break coupler may include a mating element for connecting the vial spike to the first fluid reservoir.

In another aspect of the present disclosure, the housing can include a second housing portion from which the lancet connector extends.

In another aspect of the present disclosure, the first housing portion may include a first cover member and the second housing portion may include a second cover member configured to be coupled to the first cover member and form a narrow space therebetween.

In another aspect of the disclosure, the first cover member may include an annular lip portion extending at least partially around a perimeter of the first cover member, and the second cover member includes an annular wall portion extending at least partially around a perimeter of the second cover member, the annular wall portion being adapted to receive the annular lip portion to join the first housing portion to the second housing portion in a mating arrangement.

In another aspect of the present disclosure, the annular lip portion of the first cover member may include a partition wall that extends into the narrow space formed by the first cover member and the second cover member.

In another aspect of the present disclosure, the partition wall may define a first chamber in a narrow space on a first side of the partition wall and a second chamber in a narrow space on a second side of the partition wall.

In another aspect of the disclosure, the first chamber may be fluidly connected to the vent line but not to the delivery line, and the second chamber may be fluidly connected to the delivery line but not to the vent line.

In another aspect of the disclosure, a hydrophobic filter may be housed in the first chamber.

In another aspect of the present disclosure, the spike connector may define a first channel fluidly connected to the first chamber but not to the second chamber and a second channel fluidly connected to the second chamber but not to the first chamber.

In another aspect of the present disclosure, the first channel can extend parallel to the second channel in the lancet connector.

In another aspect of the disclosure, the transfer line may include a particle filter.

In another aspect of the disclosure, the particulate filter may be housed in a second chamber arranged parallel to the hydrophobic filter.

In another aspect of the disclosure, the housing may include a third housing portion that houses the carbon filter, and the vent line may run from the first housing portion to the third housing portion and exit to atmosphere through an outlet formed through a wall of the third housing portion.

In another aspect of the disclosure, the transfer line may include a check valve.

In another aspect of the disclosure, the first cover may include an annular lip portion extending at least partially around a perimeter of the first cover, and the second cover may include an annular wall portion extending at least partially around a perimeter of the second cover, the annular wall portion adapted to receive the annular lip portion to join the first housing portion to the second housing portion in a mating arrangement.

In another aspect of the disclosure, the housing may include a third housing portion in fluid communication with the vent line, and the third housing portion may be connected to a flexible membrane that forms a gas storage volume between the third housing portion and the flexible membrane.

In another aspect of the present disclosure, a vial adapter may include a vial spike according to any of the preceding aspects and a vial clamp connectable to the vial spike.

In another aspect of the present disclosure, the vial clamp can include a proximal end having a fastener mechanism configured to be connected to a vial spike.

In another aspect of the present disclosure, the fastener mechanism can include a plurality of flexible arms, each flexible arm having a barbed end.

In another aspect of the present disclosure, the flexible arm can releasably engage a portion of the housing of the vial spike to connect the vial clamp to the vial spike.

In another aspect of the present disclosure, the vial clamp may include at least one arcuate flange forming a receptacle.

In another aspect of the present disclosure, the spike connector may extend into the socket and the at least one arcuate flange may form a guard to protect a user from accidental sticking by the spike connector.

Drawings

The drawings depict one or more implementations by way of example only and not by way of limitation. In the drawings, like reference numbers may refer to the same or similar elements.

Fig. 1 is a perspective view of a CSTD according to one embodiment.

Fig. 2 is an exploded perspective view of the CSTD of fig. 1.

Fig. 3 is a front view of the CSTD of fig. 1 shown in cross-section, wherein components of the CSTD are shown in a uncoupled state.

Fig. 4 is a front view of the CSTD of fig. 1 shown in cross-section, wherein components of the CSTD are shown in coupled and locked states.

Fig. 5 is a cross-sectional view of the CSTD of fig. 1 taken through a first section.

Fig. 6 is a cross-sectional view of the CSTD of fig. 1 taken through a second section.

Fig. 7 is a perspective view of a CSTD according to another embodiment.

Fig. 8 is an exploded perspective view of the CSTD of fig. 7.

Fig. 9 is a front view of the CSTD of fig. 7 shown in cross-section, wherein components of the CSTD are shown in a uncoupled state.

Fig. 10 is a front view of the CSTD of fig. 7 shown in cross-section with components of the CSTD shown in coupled and locked state.

Fig. 11 is a perspective view of a CSTD according to another embodiment.

Fig. 12 is an exploded perspective view of the CSTD of fig. 11.

Fig. 13 is a front view of the CSTD of fig. 11 shown in cross-section with components of the CSTD shown in a uncoupled state.

Fig. 14 is a front view of the CSTD of fig. 11 shown in cross-section with components of the CSTD shown in coupled and locked state.

Fig. 15 is a cross-sectional view of the CSTD of fig. 11 taken through a section of the housing.

Fig. 16 is a truncated cross-sectional view of a CSTD according to another embodiment.

Fig. 17 is a perspective view of a CSTD according to another embodiment.

Fig. 18 is a perspective view of the CSTD of fig. 17, wherein components of the CSTD are shown in a uncoupled state.

Fig. 19 is an exploded perspective view of the CSTD of fig. 17.

FIG. 20 is a front view of the CSTD of FIG. 17 in cross-section, wherein components of the CSTD are shown in a coupled and locked state.

Fig. 21 is a cross-sectional view of the CSTD of fig. 17 taken through a first section.

Fig. 22 is a cross-sectional view of the CSTD of fig. 17 taken through a second section.

Fig. 23 is a perspective view of a CSTD according to another embodiment.

FIG. 24 is a perspective view of the CSTD of FIG. 23, wherein the components are shown in a uncoupled state.

Fig. 25 is an exploded perspective view of the CSTD of fig. 23.

Fig. 26 is a front view of the CSTD of fig. 23 shown in cross-section through a first plane, wherein components of the CSTD are shown in a uncoupled state.

Fig. 27 is a side view of the CSTD of fig. 23 shown in cross-section through a second plane, wherein components of the CSTD are shown in a uncoupled state.

Fig. 28 is a front view of the CSTD of fig. 23 shown in cross-section through a first plane, wherein components of the CSTD are shown in coupled and locked states.

Fig. 29 is a side view of the CSTD of fig. 23 shown in cross-section through a second plane, wherein components of the CSTD are shown in coupled and locked states.

Fig. 30 is a cross-sectional view of the CSTD of fig. 23 through a third plane perpendicular to the first and second planes, where components of the CSTD are shown in coupled and locked states.

Fig. 31 is a perspective view of a CSTD according to another embodiment.

FIG. 32 is a perspective view of the CSTD of FIG. 31, wherein the components are shown in a uncoupled state.

Fig. 33 is an exploded perspective view of the CSTD of fig. 31.

Fig. 34 is a front view of the CSTD of fig. 31 shown in cross-section through a first plane, with the components shown in an uncoupled state.

Fig. 35 is a front view of the CSTD of fig. 31 shown in cross-section through a first plane, with the components shown in coupled and locked state.

Fig. 36 is a cross-sectional view of the CSTD of fig. 31 taken through a second plane perpendicular to the first plane, where the components are shown in coupled and locked states.

FIG. 37 is a front view of a CSTD showing a vial spike and vial clamp in a coupled state with a portion of the vial spike separated to depict internal components, according to another embodiment.

FIG. 38 is a perspective view of the CSTD of FIG. 37 showing the vial spike and vial holder in an uncoupled state.

FIG. 39 is a front view of the vial spike of FIG. 37.

Fig. 40 is an exploded perspective view of the vial spike of fig. 37.

Fig. 41 is an elevation view of the vial spike of fig. 37 shown in cross-section.

Fig. 42 is a bottom view of the housing portion of the vial spike of fig. 37.

FIG. 43 is a side view of the vial spike of FIG. 37 shown in cross-section.

FIG. 44 is a perspective view of the vial spike of FIG. 37 wherein the housing portion is shown transparent to illustrate the direction of flow within the vial spike.

FIG. 45 is an enlarged cross-sectional view of another embodiment of the vial spike showing an alternative arrangement.

Fig. 46 is a front view of a CSTD according to another embodiment, showing an alternative vial spike and vial clamp in a coupled state.

Fig. 47 is a perspective view of a CSTD according to another embodiment showing the vial spike and vial clamp in a coupled state.

Fig. 48 is a front view of the CSTD of fig. 47.

Fig. 49 is an exploded front view of the CSTD of fig. 47.

Fig. 50 is a first cross-sectional view of the vial spike of fig. 47.

FIG. 51 is a second cross-sectional view of the vial spike of FIG. 47.

FIG. 52 is a perspective view of a modular system for assembling a CSTD in accordance with another embodiment, wherein the components are shown in an disassembled state.

Fig. 53 is an exploded perspective view of some of the components of the modular system shown in fig. 52.

Fig. 54 is a cross-sectional view of a component of the modular system shown in fig. 52.

Fig. 55 is a top view of one of the components shown in fig. 52.

Fig. 56 is an enlarged perspective view of another component shown in fig. 52.

Fig. 57 is a top view of some of the components in fig. 52 shown in partial cross-section.

Fig. 58 is a front view of a CSTD that may be assembled from components in the modular system of fig. 52.

FIG. 59 is a front view of another CSTD that can be assembled from components in the modular system of FIG. 52.

Fig. 60 is a front view of another CSTD that may be assembled from components in the modular system of fig. 52.

Fig. 61 is a front view of another CSTD that may be assembled from components in the modular system of fig. 52.

Fig. 62 is a perspective view of a modular system for assembling a CSTD according to another embodiment, with the components shown in disassembled state.

Fig. 63 is an exploded perspective view of some of the components shown in fig. 62 that can be assembled to form a CSTD.

FIG. 64 is a top view of some of the components shown in FIG. 63, the components shown in an assembled state and in partial cross-section.

FIG. 65 is an exploded perspective view of the other components shown in FIG. 62 that can be assembled to form another CSTD.

FIG. 66 is a top view of some of the components shown in FIG. 65, the components shown in an assembled state and in partial cross-section.

Fig. 67 is a perspective view of a CSTD according to another embodiment.

Fig. 68 is a front view of the CSTD of fig. 67 shown in cross-section through a first plane, wherein components of the CSTD are shown in a coupled state.

Fig. 69 is a side view of the CSTD of fig. 67 shown in cross-section through a second plane, wherein components of the CSTD are shown in a coupled state.

Fig. 70 is an exploded perspective view of the CSTD of fig. 67.

Fig. 71 is a perspective view of a CSTD according to another embodiment.

Fig. 72 is a front view of the CSTD of fig. 71 shown in cross-section through a first plane, wherein components of the CSTD are shown in a coupled state.

Fig. 73 is a side view of the CSTD of fig. 71 shown in cross-section through a second plane, wherein components of the CSTD are shown in a coupled state.

Fig. 74 is an exploded perspective view of the CSTD of fig. 71.

Fig. 75 is a perspective view of a CSTD according to another embodiment.

Fig. 76 is a side view of the CSTD of fig. 75 shown in cross-section through a first plane, wherein components of the CSTD are shown in a coupled state.

Fig. 77 is a front view of the CSTD of fig. 75 shown in cross-section through a second plane, wherein components of the CSTD are shown in a coupled state.

Fig. 78 is a top view of the CSTD of fig. 75 shown in cross-section through a third plane, wherein components of the CSTD are shown in a coupled state.

Fig. 79 is an exploded perspective view of the CSTD of fig. 75.

Fig. 80 is a perspective view of a CSTD according to another embodiment.

FIG. 81 is a side view of the CSTD of FIG. 80 shown in cross-section through a first plane, wherein components of the CSTD are shown in a coupled state.

Fig. 82 is a front view of the CSTD of fig. 80 shown in cross-section through a second plane, wherein components of the CSTD are shown in a coupled state.

Fig. 83 is a top view of the CSTD of fig. 80 shown in cross-section through a third plane, wherein components of the CSTD are shown in a coupled state.

Fig. 84 is an exploded perspective view of the CSTD of fig. 80.

Fig. 85 is a perspective view of a CSTD according to another embodiment.

FIG. 86 is another perspective view of the CSTD of FIG. 85, wherein components of the CSTD are shown in an uncoupled state.

Fig. 87 is an exploded perspective view of the CSTD of fig. 85.

FIG. 88 is a front view of the CSTD of FIG. 85 in cross-section, wherein components of the CSTD are shown in an uncoupled state.

FIG. 89 is a front view of the CSTD of FIG. 85 in cross-section, wherein components of the CSTD are shown in a coupled and locked state.

Fig. 90 is a front view of a CSTD according to another embodiment, where components of the CSTD are shown in a non-coupled state.

FIG. 91 is a front view of the CSTD of FIG. 90, wherein components of the CSTD are shown in a partially inserted state.

FIG. 92 is a front view of the CSTD of FIG. 90, wherein components of the CSTD are shown in a coupled and locked state.

Fig. 93 is a front view of a CSTD according to another embodiment, where components of the CSTD are shown in a non-coupled state.

Fig. 94 is a front view of the CSTD of fig. 93, wherein components of the CSTD are shown in a partially inserted state.

FIG. 95 is a front view of the CSTD of FIG. 93, wherein the components of the CSTD are shown in a coupled and locked state.

Detailed Description

In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. It should be understood that these examples are non-limiting. Many modifications, changes, substitutions, and combinations will now occur to those skilled in the art without departing from the scope of the disclosure and its teachings, and these modifications, changes, substitutions, and combinations are part of this disclosure. This includes replacing features shown in one example with features shown in another example, or a combination of features shown in one example with features shown in another example. All alternatives and combinations are considered part of this written description.

The following description uses various defined terms to describe individual and discrete physical arrangements and/or orientations. The term "longitudinal axis (longitudinal axis)" refers to or refers to the long dimension of an element through which the central axis of the element extends. The terms "axial" and "axial" mean or refer to a direction parallel to the longitudinal axis. The terms radial and radial refer to or refer to directions perpendicular to the longitudinal axis. When used with "radial" the terms "inward" and "inward" refer to directions toward the longitudinal axis in a radial direction. When used with "radial" the terms "outward" and "outward" refer to directions away from the longitudinal axis in a radial direction.

Referring to fig. 1 and 2, a CSTD 100 according to a first embodiment is shown. CSTD 100 has a first adapter 120 configured to attach to a first fluid reservoir and a second adapter 140 configured to attach to a second fluid reservoir. For example, the first adapter 120 may be connected to a vial, a bag, or a patient line. The second adapter 140 has a female luer connector 180 that can be connected to any male luer connector on a syringe or fluid delivery device, such as a pump. Once first adapter 120 and second adapter 140 are attached to the first fluid reservoir and second fluid reservoir, respectively, and are interconnected to one another in the coupled state shown in FIG. 1, CSTD 100 forms a closed fluid channel between the first fluid reservoir and the second fluid reservoir. The closed fluid channel is isolated from the external environment, preventing contaminants from flowing into the system and preventing harmful vapors from being released from the system.

The first adapter 120 has a generally rectangular body 121. The second adapter 140 has a generally rectangular socket or housing 141. The housing 141 is adapted to receive the body 121 of the first adapter 120 in a guided manner such that the two adapters are axially aligned and centered during mating. The housing 141 has a hollow interior 143 and a slot 145 adapted to receive the first adapter 120 during mating. As shown, two cutouts extend on opposite sides of the slot 145. The cutout provides easier access to the interior of the housing 141 than conventional adapters. Easier access to the interior allows both sides of the device to be more easily sterilized.

Fig. 3 shows a cross section of the first adapter 120 and the second adapter 140 before being coupled together. The first adapter 120 has a first passageway 126 and a first diaphragm 128 made of an elastomeric material. The first channel 126 has a first channel end 126a and a second channel end 126b opposite the first channel end. The first channel end 126a defines a first opening 126c and the second channel end 126b defines a second opening 126d. The first channel 126 widens at a second channel end 126b to form a cylindrical chamber or seat 129. The first diaphragm 128 is received in the seat 129 to seal the second channel end 126b. A portion of the first diaphragm 128 extends axially from the second opening 126d, forming a first protrusion 128g.

The second adapter 140 has a second channel 146 and a second diaphragm 148 made of an elastic material. The second channel 146 has a first channel end 146a and a second channel end 146b opposite the first channel end. The first channel end 146a defines a first opening 146c and the second channel end 146b defines a second opening 146d. The first channel 146 widens at a second channel end 146b to form a cylindrical cavity or seat 149. The second diaphragm 148 is received in a seat 149 to seal the second channel end 146b. A portion of the second membrane 148 extends axially from the seat 149 forming a second protrusion 148g. The second projection 148g is configured to abut the first projection 128g and be deformed by the first projection 128g and vice versa to form a dry-break coupler. As used herein, "dry break coupling (dry break coupling)" means a coupling that prevents the release of liquid or vapor from the CSTD during coupling or uncoupling of two components.

The second membrane 148 is contained in a carrier 150 carrying the second membrane. The carrier 150 is configured to slide axially within the housing 141 between a first position and a second position. Fig. 3 shows the carrier 150 in a first position. The carrier 150 has two flexible clamps 152 made of a resiliently flexible material. In the relaxed state, the clamps 152 extend outwardly in a parallel arrangement. However, the clamp according to the present disclosure may also extend in a non-parallel arrangement in a relaxed state. For example, the clamps may also be slightly flared outwardly and away from each other at their free ends. As will be explained, this will allow the clip to store more energy when flexed inwardly.

Each clip 152 has a clip end 153 with a rounded protrusion 154 extending radially outward from the clip and a pointed tip 155 extending radially inward from the clip. When the carrier is in the first position, each rounded protrusion 154 rests against a tapered platform 147 formed in the housing 141. The clamp 152 engages the platform 147 to hold the carrier in the first position wherein the second diaphragm is positioned adjacent the slot 145 of the housing 141. Fig. 3 shows the carrier 150 in a first position, wherein the clamp 152 is in an outwardly relaxed position engaged with the platform 147.

The first adapter 120 is connected to the second adapter 140 by inserting the body 121 into the slot 145 and the hollow interior 143 of the second adapter 140 until the first membrane 128 contacts the second membrane 148. Once first membrane 128 abuts second membrane 148, movement of carrier 150 from the first position is prevented by engagement between clamp 152 and platform 147. This resistance is overcome by applying a manual force to the first adapter 120 in an axial direction toward the second diaphragm 148 until the manual force exceeds the resistance.

The seat 129 in the first adapter 120 has an outer wall 129a. When the first adapter 120 is moved into the hollow interior 143 through the slot 145, the outer wall 129a temporarily engages and slides against the prongs 155 of the clamp 152. This holds the clamp 152 in its rest position against the platform 147 and prevents the clamp from flexing inwardly. The outer wall 129 tapers inwardly at the transition 123. In this arrangement, the first adapter 120 can be inserted into the second adapter 140 such that the outer wall 129a travels between the clips 152 and slides through the prongs 155.

Once the outer wall 129a travels past the prongs 155, the prongs slide over the outer wall and reach the transition 123. In this position, the outer wall 129a no longer prevents the clip 152 from flexing inwardly because the narrower dimension at the transition 123 provides a gap that allows the clip to flex inwardly. The hollow interior 143 of the second adapter 140 narrows as it extends inwardly from the platform 147. Thus, further advancement of the first adapter 120 into the second adapter 140 causes the clamp ends 153 to flex inward such that they no longer bear against the platform 147. In this position, the carrier 150 is free to move from a first position to a second position in the housing 141. Fig. 4 shows the first adapter 120 fully inserted into the second adapter 140, wherein the carrier 150 is moved to the second position and the clip 152 is deflected inwardly.

The hollow interior 143 of the second adapter 140 has a wider section 143a at the slot 145, which is shown in fig. 4 above the platform 147. The hollow interior 143 transitions into a narrower section 143b below the platform. When the carrier 150 is pushed from the first position to the second position, the circular protrusion 154 on the clamp 152 slides and bears against the inner wall 141a of the housing 141. This abutment between the rounded protrusion 154 and the inner wall 141a causes the clip 152 to flex inwardly as it enters the narrower section 143b of the hollow interior 143. The prongs 155 of the clip 152 are pushed inwardly and rest against the protrusions 125 on the outer wall 129a of the first adapter 120.

As shown in fig. 3 and 4, the second adapter 140 houses a needle 160. The needle 160 is axially secured to the female luer connector 180. The female luer connector 180 is axially movable relative to the housing 141 through a small axial distance, but is restricted from moving beyond a small range of motion. In this arrangement, the needle 160 is forcibly fixed in the housing 141 of the second adapter 140 and is only allowed to move a small axial distance relative to the housing, after which further axial movement is stopped. Instead, the carrier 150 and the second diaphragm 148 are axially movable relative to the housing 141 through a majority of the length of the hollow interior 143.

Various mechanisms may be used to limit axial movement of the female luer connector and needle relative to the housing. Examples include snap-fit arrangements such as those shown in U.S. patent nos. 5,328, 474 and 7,857, 805, the contents of which are incorporated herein by reference in their entirety. Fig. 16 shows a modified female luer connector 180 'having a snap-fit arrangement utilizing barbed extensions 182'. The barb extension 182' protrudes through the inner wall 142' of the housing 141' and into the hollow interior of the housing. The housing 141' has a collar 143' with annular pawls 145' in its interior. The barb extension 182 'has a tapered leading end 183' of widened outer diameter. Annular pawl 145 'forms a constricted passage 146' within collar 143 'having a diameter smaller than the outer diameter of forward end 183'. In this arrangement, the barb extension 182' may be inserted through the inner wall 142' and the collar 143' in a press-fit manner to attach the female luer connector 180' to the housing 141'. As shown, annular pawl 145 'has a tapered surface facing inner wall 142' that deflects or deforms slightly to allow forward end 183 'to travel past the pawl and emerge from collar 143'. The flange portion 147 'of the female luer connector 180' abuts the inner wall 142 'of the housing 141' on the side opposite the collar 143 'to limit further axial displacement of the female luer connector and needle 160' into the housing. If the female luer connector 180 'is shifted in a direction opposite to the insertion direction, the front end 183're-enters the collar 143 'but abuts the annular pawl 145'. Such abutment prevents the female luer connector 180 'from being inverted or pulled out of the housing 141'. As a result, the female luer connector 180 'and the needle 160' remain in a forced arrangement within the interior wall 142 'of the housing 141'.

The first membrane 128 and the second membrane 148 are formed of an elastic material that can be pierced by the needle 160 when the carrier 150 is pushed towards the second position. The needle 160 has a side opening 162 that remains sealed within the carrier 150 prior to coupling the second adapter 140 to the first adapter 120. The side opening 162 is sealed within the narrowed section 146e of the second channel 146. The narrowed section 146e is sealed at a first end by a second membrane 148 and at a second end by a third membrane 158.

As the first adapter 120 advances into the housing 141, the first diaphragm 128 pushes against the second diaphragm 148 and moves the second diaphragm and carrier 150 downward in the housing. The second membrane 148 and carrier 150 move downward over the needle 160, which moves a small axial distance relative to the housing 141, and is then stopped from further axial displacement. The needle 160 has a sharpened tip 164 configured to pass through the first septum 128 and the second septum 148. Once the needle 160 stops further axial movement, the carrier 150 moves downward over the needle 160 until the needle tip 164 passes through the second septum 148, at which point the needle tip immediately enters the first septum 128. During this movement, the side opening 162 of the needle 160 travels through the second septum 148 and immediately into the first septum 128. Accordingly, side opening 162 remains isolated from the interior and exterior regions of CSTD 100 after emerging from second membrane 148 and traveling into first membrane 128.

As the carrier 150 moves down over the needle 160, the side opening 162 moves through three sealing positions relative to the other components. In the first sealing position, as shown in fig. 3, the side opening 162 is sealed between the second diaphragm 148 and the third diaphragm 158. In the second sealing position, the side opening 162 is sealed within the second diaphragm 148. In the third sealing position, the side opening 162 is sealed within the first diaphragm 128. Once the carrier 150 bottoms out in the receptacle, the first membrane 128 is pushed downwardly through the side opening 162 such that the side opening 162 emerges from the first membrane and is exposed in the first channel 126 of the first adapter 120. In this state, the side openings 162 form a communication fluid path between the first adapter 120, the second adapter 140, and their respective reservoirs to which the adapters are connected.

When the carrier 150 reaches the second position, the first protrusion 128g on the first membrane 128 abuts the second protrusion 148g on the second membrane 148 to form a dry break coupler. The elastomeric materials of the first membrane 128 and the second membrane 148 compress together automatically closing and isolating the space between the needle opening 162 and the interior space CSTD 100 so that liquid and vapor cannot escape, leak or escape from the device.

The second adapter 140 has a pair of stationary locking ramps 170 along the inner wall 144. Carrier 150 has corresponding pairs of lugs 151. The tab 151 is configured to slidingly engage the locking ramp 170 when the carrier 150 is moved to the second position. Once the carrier 150 reaches the second position, the lugs 151 lockingly engage the ramps 170. This engagement locks CSTD 100 in a "fluid path open" state, wherein needle 160 provides a fluid path between first adapter 120 and second adapter 140 and their respective reservoirs.

Each lug 151 projects radially outwardly on flexible arms 156. When the carrier 150 is pushed to the second position, the lugs 151 contact the locking ramps 170. The locking ramp 170 has a ramp surface 171 that extends radially inward in the hollow interior 143 of the housing 141 when the ramp surface extends toward the female luer connector 180. This orientation of ramp surface 171 causes lugs 151 and flexible arms 156 to flex radially inward, wherein energy is stored in the flexible arms. As the carrier 150 moves toward the second position, the lugs 151 slide along the ramp surfaces 171, flexing further radially inward until the lugs clear the ends of the locking ramps 170. At this time, the carrier 150 bottoms out in the housing 141 to the second position shown in fig. 4. In addition, the locking ramp 170 no longer contacts the lugs 151, allowing the lugs to snap outwardly into a relaxed state when energy is released from the flexible arms 156. In this state, the lugs 151 engage the locking ramps 170 to prevent the carrier 150 from moving back toward the first position. This locks the carrier 150 in the second position, wherein the device is locked in the "fluid path open" state described previously.

After fluid is delivered through CSTD 100, first adapter 120 remains locked within second adapter 140 by the engagement of locking ramp 170 and ledge 151. The first adapter 120 may be released from the second adapter 140 by applying a radially inward force F to a pair of side buttons 142 built into the side walls of the housing 141. The direction of force F is indicated by the arrow in fig. 4.

When the side button 142 is pressed radially inward, the side button pushes the lugs 151 radially inward until the lugs are no longer axially aligned with the locking ramps 170. At this stage, the locking ramp 170 no longer prevents the carrier 150 from moving back from the second position to the first position. Thus, the first adapter 120 can be removed from the hollow interior 143 of the second adapter 140 by pressing the side button 142 inward to release the carrier 150 and pulling the first adapter out of the hollow interior and the slot 145.

When the first adapter 120 is withdrawn from the hollow interior 143, the protruding portion 125 on the first adapter remains engaged with the underside of the clamp end 153. This engagement causes carrier 150 to be pulled or pulled back to a first position in housing 141 as first adapter 120 is withdrawn from the housing. When the carrier 150 reaches the first position, the clamp end 153 exits the narrower section 143b of the hollow interior 143 and enters the wider section 143a. This causes the clamp ends 153 to snap outwardly to the position shown in fig. 3. The outward movement of the clip end 153 releases the clip end from the projection 125 on the first adapter 120. Thus, the protruding portion 125 is released from the clamp 152, allowing the first adapter 120 to be completely pulled out of the housing 141 and separated from the second adapter 140. The carrier 150 is prevented from being pulled out of the housing 141 by the lugs 151 engaging the undercuts 141b in the inner wall 141a of the housing 141.

CSTDs according to the present disclosure may include one or more alignment structures that maintain the components in proper axial and radial alignment as the components move relative to one another. For example, CSTD 100 includes longitudinal ribs 141d along the inner wall 141a of housing 141, a portion of which is shown in FIG. 2. As shown in fig. 5, the ribs 141d are configured to engage longitudinally extending indentations 157 on the carrier 150 to maintain proper alignment between the carrier and the housing 141. Further, as shown in fig. 6, the ribs 141d are configured to engage the longitudinally extending slots 127 on the first adapter 120 to maintain proper alignment between the first adapter and the housing 141.

CSTD 100 has the same features and characteristics in structure and/or function as other embodiments described in this disclosure. Thus, for the sake of brevity, some features described on CSTD 100 will not be described on other embodiments, with the understanding that these features also exist on other embodiments.

Referring to fig. 7 and 8, a CSTD 200 according to a second embodiment is shown. CSTD 200 has a first adapter 220 configured to attach to a first fluid reservoir and a second adapter 240 configured to attach to a second fluid reservoir. For example, the first adapter 220 may be connected to a vial, a bag, or a patient line. The second adapter 240 has a female luer connector 280 that may be connected to any male luer connector on a syringe or fluid delivery device, such as a pump. Once the first adapter 220 and the second adapter 240 are attached to the first fluid reservoir and the second fluid reservoir, respectively, and interconnected to each other in the coupled state shown in FIG. 7, the CSTD 200 forms a closed fluid channel between the first fluid reservoir and the second fluid reservoir.

The first adapter 220 has a generally cylindrical body 221. The second adapter 240 has a generally cylindrical socket or housing 241. The housing 241 of the second adapter 240 is adapted to receive the body 221 of the first adapter 220 to interconnect the two adapters. The cylindrical geometry of the first adapter 220 and the second adapter 240 allows the first adapter to be inserted into the second adapter in any orientation relative to the second adapter. No specific orientation is required to properly insert the first adapter 220 into the second adapter 240 to connect the two. This simplifies the connection of the adapter and results in a reduced chance of a user making mistakes when connecting the adapter.

Fig. 9 shows a cross section of the first adapter 220 and the second adapter 240 before being coupled together. The first adapter 220 has a first channel 226 and a first diaphragm 228 made of an elastic material. The first channel 226 has a first channel end 226a and a second channel end 226b opposite the first channel end. The first channel end 226a defines a first opening 246c and the second channel end 246b defines a second opening 246d. The first channel 226 widens at a second channel end 246b to form a cylindrical chamber or seat 229. The first diaphragm 228 is received in the seat 229 to seal the second channel end 226b. A portion of the first diaphragm 228 extends axially from the second passage opening 226d, forming a first projection 228g.

The second adapter 240 has a second channel 246 and a second diaphragm 248 made of an elastomeric material. The second channel 246 has a first channel end 246a and a second channel end 246b opposite the first channel end. The first channel end 246a defines a first opening 246c and the second channel end 246b defines a second opening 246d. The second channel 246 widens at a second channel end 246b to form a cylindrical chamber or seat 249. A portion of second diaphragm 248 is received in seat 249 to seal second channel end 246b.

Second diaphragm 248 has an elongated cylindrical body that acts as collapsible piston 248a. Piston 248a has a head 248b, a collapsible middle section 248c, and a bottom flange 248d. The collapsible middle section 248c has a smaller diameter than the head 248b and bottom flange 248d. A series of circumferential ribs 248e extend along the length of the collapsible middle section 248 c. The bottom flange 248d is fitted into the cylindrical recess 242 in the housing 241.

The head 248b of the second membrane 248 is contained within a carrier 250. The carrier 250 has a collet portion 252 and a hollow cylindrical bottom 254. The bottom 254 defines the aforementioned cylindrical chamber or seat 249. The cylindrical chamber or seat 249 is sized such that the head 248b engages the interior of the bottom 254 in a fluid tight fit. The bottom 254 has an opening 254a that interconnects the cylindrical chamber or seat 249 with the interior of the collet portion 252. An end 248f of second diaphragm 248 protrudes through opening 254a, forming a second protrusion 248g that extends into collet portion 252. The second protrusion 248g is configured to abut the first protrusion 228g and be deformed by the first protrusion 128g and vice versa to form a dry-break coupler.

The carrier 250 is configured to slide axially within the housing 241 between a first position and a second position. Fig. 9 shows the carrier 250 in a first position. The collet portion 252 has four flexible clamps 252a made of a resiliently flexible material. In the relaxed state, the clamp 252a extends radially outward in an expanded arrangement. Each clip 252a has a clip end 253 with an outer protrusion 253a extending radially outward and an inner detent 253b extending radially inward. When the carrier 250 is in the first position, each external protrusion 253a rests against a tapered platform 247 in the housing 241. The external protrusion 253a engages the platform 247 to hold the carrier 250 in the first position.

The first adapter 220 is connected to the second adapter 240 by inserting the body 221 of the first adapter 220 into the housing 241 of the second adapter 240 and between the clips 252a of the carrier 250. The body 221 is advanced until the first diaphragm 228 contacts the protrusion 248g of the second diaphragm 248. Once first diaphragm 228 contacts second diaphragm 248, movement of carrier 250 from the first position is prevented by the engagement between clamp 252a and platform 247. This resistance is overcome by applying a manual force to first adapter 220 in an axial direction toward second diaphragm 248 until the manual force exceeds the resistance.

The seat 229 in the first adapter 220 is surrounded by a wedge plug section 229 a. As the first adapter 220 moves into the collet portion 252, the plug segment 229a travels between the collets 252 a. The inner wall 241a of the housing 241 tapers radially inwardly as the inner wall extends from the platform 247. As the carrier 250 moves out of the first position toward the second position, the clamp end 253 bearing against the inner wall 241a is compressed radially inward by the inner wall under stored energy. This radial compression pushes the pawls 253b radially inward against a shoulder 229b extending circumferentially around the plug segment 229 a. The engagement between the detent 253b and the shoulder 229b temporarily interlocks the carrier 250 and the first adapter 220. In this case, the carrier 250 is free to move from the first position to the second position in the housing 241. As the carrier 250 moves toward the second position, the collapsible middle section 248c is axially compressed. Fig. 10 shows the first adapter 220 fully inserted into the second adapter 240, wherein the carrier 250 is moved to the second position. In this position, the clamp 252s flexes radially inward under the stored energy and the collapsible middle section 248c is compressed axially under the stored energy.

As shown in fig. 9 and 10, the second adapter 240 houses a needle 260. The needle 260 is axially secured to the female luer connector 280. The female luer connector 280 may be axially movable relative to the housing 241 through a small axial distance, but is restricted from movement beyond a small range of movement by a snap-fit arrangement or other forced configuration as described in the first embodiment. In this arrangement, the needle 260 is forcibly fixed in the housing 241 of the second adapter 240 and is only allowed to move a small axial distance relative to the housing before stopping further axial movement. Instead, carrier 250 and head 248b of second diaphragm 248 are axially movable relative to housing 241 through a majority of the length of the housing.

When carrier 250 is urged toward the second position, first diaphragm 228 and second diaphragm 248, which are formed of an elastomeric material, may be pierced by needle 260. Needle 260 has a side opening 262 that remains sealed within second septum 248 prior to coupling second adapter 240 to first adapter 220. As the first adapter 220 advances into the housing 241, the first diaphragm 228 pushes against the second diaphragm 248 and moves the head 248b and carrier 250 downward in the housing. As described in the first embodiment, the head 248b and carrier 250 move downward over the needle 260, which moves a small axial distance relative to the housing 241, and is then stopped from further axial displacement by a snap fit arrangement or other forced configuration. Needle 260 has a sharpened tip 264 configured to pass through first septum 228 and head 248b. Once needle 260 stops further axial movement, carrier 250 moves downward over needle 260 until needle tip 264 passes through second septum 248 and into first septum 228. During this movement, side opening 262 of needle 260 travels through second septum 248 and immediately into first septum 228.

As the carrier 250 moves downward over the needle 260, the side openings 262 move through three sealing positions relative to the other components. In the first sealed position, side opening 262 is sealed within narrow hollow core 248h within collapsible middle section 248c of second diaphragm 248. This position is shown in fig. 9. In the second sealing position, side opening 262 is sealed within head 248b of second diaphragm 248. In the third sealing position, side opening 262 is sealed within first diaphragm 228. As shown in fig. 10, once the carrier 250 bottoms out in the second adapter 240, the first diaphragm 228 is pushed downwardly through the side opening 262 such that the side opening emerges from the first diaphragm and is exposed in the first channel 226 of the first adapter 220. In this state, the side opening 262 forms a communication fluid path between the second adapter 240 and the first adapter 220. When carrier 250 reaches the second position, first diaphragm 228 and second diaphragm 248 form a dry-break coupling.

The first adapter 220 has a circumferential flange 230 extending radially outwardly from the body 221. The second adapter 240 has a pair of stationary clips 270 pivotally connected to the wall 245 of the housing 241. Each mounting clip 270 is pivotally connected to the wall 245 on a resilient hinge 270 a. The hinge 270a allows each mounting clip 270 to pivot through an opening 245a in the wall 245. When the first adapter is inserted into the second adapter 240, the flange 230 on the first adapter 220 travels between the mounting clips 270. As shown in fig. 9, the fixing clip 270 is formed of a resiliently flexible material and defines a space therebetween in a relaxed state. Each fixation clamp 270 has a barb-shaped clamp end 271 with two engagement surfaces. The first engagement surface is a radially inwardly facing ramped contact surface 272 on the second adapter. The second engagement surface is an undercut surface 273 extending perpendicular to the longitudinal axis.

When the fixing clip 270 is in a relaxed state, the diameter of the flange 230 is greater than the space between the clip ends 271. Thus, as flange 230 travels between fixtures 270, the flange bears against sloped contact surface 272. The beveled contact surface 272 is oriented such that an axial force applied to the first adapter 220 toward the second adapter 240 displaces the retention clip 270 radially outward relative to the axis of the second adapter. The mounting clip 270 flexes radially outward and expands under the stored energy to allow the flange to travel past the ramped contact surface 272.

Once the flange 230 has moved away from the ramped contact surface 272, the clamp 270 is no longer subjected to a force that displaces it outwardly. Thus, as shown in FIG. 10, when the energy is released, the clamp 270 snaps back into a relaxed state with the undercut surface 273 of the clamp positioned over the flange 230. The axial engagement between the undercut surface 273 and the flange 230 prevents the first adapter 220 from being removed from the second adapter 220, thereby locking them together. The moment when the clip 270 snaps over the flange 230 preferably coincides with the location where the side opening 262 is fully exposed from the first diaphragm and exposed in the first channel 226. It also preferably coincides with the carrier 250 reaching the second position. Thus, when the carrier 250 reaches the second position, the first adapter 220 and the second adapter 240 are locked together in a "fluid path open" state, wherein the needle provides a fluid path between the first adapter and the second adapter and their respective reservoirs. The clamp 270 bears against the flange 230 to lock the first and second adapters 220, 240 together while resisting the axial expansion force exerted by the collapsible middle section 248c in its compressed state. This causes the first adapter 220 and the second adapter 240 to be locked together under tension. The snap-fit of clamp 270 over flange 230 produces an audible click informing the user that CSTD 200 is locked in the fluid path open state.

After the fluid is delivered through CSTD 200, first adapter 220 remains locked within second adapter 240 by the engagement between fixture 270 and flange 230. The first adapter 220 may be released from the second adapter 240 by applying a radially inward force F to a pair of side buttons 274 extending radially outward from the stationary fixture 270. The direction of force F is indicated by the arrow in fig. 10.

When the side button 274 is pressed radially inward, the stationary fixture 270 pivots through an opening 245a in the wall 245 and stores energy at the hinge 270 a. The clamp ends 271 pivot radially outwardly and away from the first adapter 220 such that the clamp ends move out of their locked position to release the position. In the released position, the undercut surface 273 no longer obstructs the flange 230 on the first adapter 220, allowing the flange to be withdrawn from the mounting clip 270 and allowing the first adapter to be withdrawn from the second adapter 240.

As described above, the clamp end 253 of the carrier 250 is pressed inwardly and wrapped around the plug section 229a of the first adapter 220. Thus, withdrawal of the first adapter 220 also pulls or withdraws the carrier 250 back to the first position. Once the clamp end 253 is axially aligned with the platform 247, the energy stored in the clamp end is released, causing the clamp end to expand and return to the relaxed state shown in fig. 9. This releases the plug section 229a from the grip of the collet portion 252, allowing the first adapter 220 to be separated from the second adapter 240.

When side button 274 is pressed inward to release flange 230 from clamp 270, the force securing collapsed piston 248a in the compressed state is removed. Thus, the energy stored in the collapsible middle section 248c of the second membrane 248 is released, causing the collapsible middle section to expand. When the collapsible middle section 248c expands, the head 248b applies a spring force to the carrier 250 that helps the carrier return to the first position. The spring force also pushes the head 248b back to the original position to enclose the needle tip 264 within the second septum 248 immediately after the first septum 228 is moved away from the needle tip. This provides a safety feature that protects the needle tip 264 after the first adapter 220 is removed from the housing 241. The needle tip 264 is never exposed before, during or after use of the CSTD 200.

Referring to fig. 11 and 12, a CSTD 300 according to a third embodiment is shown. CSTD 300 has a first adapter 320 configured to attach to a first fluid reservoir and a second adapter 340 configured to attach to a second fluid reservoir. For example, the first adapter 320 has a spike 322 that can be connected to a vial. The second adapter 340 has a female luer connector 380 that can be connected to any male luer connector on a syringe or fluid delivery device, such as a pump. The needle 360 is housed within the second adapter 340 and forms a fluid conduit in communication with the first adapter 320 as will be described. Once the first and second adapters 320 and 340 are attached to the first and second fluid reservoirs, respectively, and interconnected with each other in the coupled state shown in FIG. 11, the CSTD 300 forms a closed fluid channel between the first and second fluid reservoirs.

The first adapter 320 has a generally cylindrical body 321. The second adapter 340 has a generally cylindrical socket or housing 341 with a cylindrical wall 342. The housing 341 of the second adapter 340 is adapted to receive the body 321 of the first adapter 320 to interconnect the two adapters. The first adapter 320 and the second adapter 340 are connected by inserting the first adapter into the second adapter by axial pushing and then rotating or twisting one adapter relative to the other adapter to lock the first adapter and the second adapter together.

The first adapter 320 has a cylindrical plug 324 and a plurality of resiliently flexible snap arms 326 arranged circumferentially around the plug. The snap arms 326 are separated from the exterior of the plug 324 by a small radial gap 328. The cylindrical wall 342 of the second adapter 340 has an inner diameter that is greater than the outer diameter of the plug 324. The inner diameter between the snap arms 326 is greater than the outer diameter of the cylindrical wall 342. In this arrangement, housing 341 is sized to telescopically receive plug 324. In addition, a radial gap 328 between the plug 324 and the snap arm 326 is sized to telescopically receive the cylindrical wall 342.

The snap arms 326 of the first adapter 320 are configured to snap over the protrusions 344 on the second adapter 340 when the first adapter is fully inserted into the second adapter. Referring to fig. 13-15, the projection 344 projects radially outwardly from the cylindrical wall 342 along a portion of its circumference and has a tapered outer sidewall 344a. Each snap arm 326 has a barbed end 327 with a tapered front face 328. The tapered front face 328 of each snap arm 326 is configured to contact the tapered outer sidewall 344a of the protrusion 344 when the first adapter 320 is inserted into the second adapter 340.

Each tapered front face 328 is oriented at an angle such that contact between the tapered front face and the projection 344 causes the snap arms 326 to flare or flex radially outward. As the first adapter 320 advances into the second adapter 340, the snap arms 326 flex radially outward under the stored energy until the barbed ends 327 pass over and clear the protrusions 344. Once the barbed end 327 leaves the protrusion 344, the stored energy in the snap arms 326 is released, causing the snap arms to snap radially inward, the barbed end hooking over the protrusion.

Once the first adapter 320 is fully inserted into the second adapter 340, the first adapter may be rotated relative to the second adapter between an axially locked position and an axially unlocked position, the axially locked position comprising a range of orientations relative to the second adapter. In the axially locked position, the barbed end 327 of the snap arm 326 is hooked over the projection 344. In the axially unlocked position, the first adapter 320 is oriented relative to the second adapter 340 such that the barbed ends 327 of the snap arms 326 are aligned only with the openings or channels 348 through the tabs 344. The channel 348 divides the protrusion 344 into arcuate protruding sections 344a and is arranged around the protrusion to align with the snap arms 326 when the first adapter 320 is rotated to a particular orientation relative to the second adapter 340. The first adapter 320 and the second adapter 340 may have any number of channels, protruding sections, and snap arms, and the example shown in fig. 1 does not represent the only arrangement contemplated.

Once the first adapter 320 is rotated to the unlocked position, each channel 348 is wide enough to allow at least one barbed end 327 in the snap arm 326 to travel through the channel. The locked and unlocked positions of the first adapter 320 may be detected by visual and tactile means. The second adapter 340 has a pair of diametrically opposed hard stops 347 that project from the cylindrical wall 342 and extend axially. The hard stop 347 is positioned relative to the protruding section 344a and the channel 348 to create a rotation limiter upon insertion of the first adapter 320 into the second adapter 340. After the first adapter 320 is fully inserted into the second adapter 340, the first adapter is rotated clockwise until one of the barbed ends 327 collides with one of the hard stops 347. In this relative orientation, at least some of the barbed ends 327 hook over the protrusions 344, preventing the first adapter 320 from being pulled out of the second adapter 340. The hard stop 347 upon clockwise rotation, which collides with the barbed end 327, provides a tactile indicator that the first adapter is locked to the second adapter.

The first adapter 320 may also be rotated in a counter-clockwise direction in a similar manner until one of the barbed ends 327 collides with the other hard stop 347. In this relative orientation, all of the barbed ends 327 are axially aligned with the passageway 348, allowing the first adapter 320 to be pulled from the second adapter 340. Thus, the hard stop 347 encountered after counter-clockwise rotation provides a tactile indicator that the first adapter 320 is unlocked from the second adapter 340 and can be pulled out of the second adapter.

The cylindrical geometry of the first adapter 320 and the second adapter 340 allows the first adapter to be inserted into the second adapter in any orientation relative to the second adapter. No particular orientation is required to properly insert the first adapter 320 into the second adapter 340 to connect the two. This simplifies the connection of the adapter and results in a reduced chance of a user making mistakes when connecting the adapter. However, first adapter 320 must be rotated clockwise until one of hard stops 347 is encountered to ensure that the first adapter is locked, and must be rotated counter-clockwise until the other of hard stops 347 is encountered to determine when the first adapter is unlocked.

Fig. 13 shows a cross section of the first adapter 320 and the second adapter 340 before being coupled together. The first adapter 320 has a first channel 323 and a first diaphragm 325 made of an elastic material. The first channel 323 has a first channel end 323a and a second channel end 323b opposite the first channel end. The first channel end 323a defines a first opening 323c and the second channel end 323b defines a second opening 323d. An annular seat 329, best shown in fig. 12, is formed around the outer wall 323e surrounding the second channel end 323b. The first diaphragm 325 is received in the seat 329 and closes the second opening 323d to seal the second channel end 323b.

The second adapter 340 has a second channel 346 and a second diaphragm 352 made of an elastomeric material. The second channel 346 has a first channel end 346a and a second channel end 346b opposite the first channel end. The first channel end 346a defines a first opening 346c and the second channel end 346b defines a second opening 346d. The second channel end 346b forms a cylindrical chamber or seat 349. The second diaphragm 352 is received in a seat 349 to seal the second channel end 346b. As with the other embodiments, the first membrane 325 has a first protrusion 325g and the second membrane 352 has a second protrusion 352g configured to form a dry break coupler with the first protrusion.

The second diaphragm 352 has an elongated cylindrical body that acts as a collapsible piston 352a. The piston 352a has a head 352b, a collapsible middle section 352c, and a bottom flange 352d. A thermoplastic housing or carrier 350 surrounds the head 352a. The carrier 350 allows continued inward pressure on the needle 360 through the restraining action of the carrier, thereby preventing radial expansion of the elastomer of the head 352a to ensure adequate sealing. The collapsible middle section 352c has a series of circumferential ribs 352e extending along the length of the collapsible middle section 352 c. The bottom flange 352d is fitted into the cylindrical recess 343 in the housing 341.

When the first adapter 320 is inserted into the housing 341 of the second adapter 340, the first diaphragm 325 presses against the second diaphragm 352. Furthermore, the plug 324 is axially supported against the carrier 350. The axial force applied to the head 352b of the second diaphragm 352 and the carrier 350 moves the second diaphragm and the carrier in an axial direction toward the bottom flange 352d of the second diaphragm. Further, collapsible midsection 352c of second diaphragm 352 collapses in response to an axial load applied to head 352 b. The carrier 350 is initially disposed at a first location at the mouth of the housing 341 and advanced to a second location deeper into the housing. During this stroke, the carrier 350 slides along the inner wall 345 of the housing 341. The inner wall 345 abruptly transitions from a larger inner diameter to a smaller inner diameter at the constriction 345 a. The constriction 345a forms an end wall or stop that abuts a circumferential stop flange 350a on the carrier 350 when the carrier reaches the second position. Thus, when the carrier reaches the second position, the carrier 350 bottoms out in the housing 341 and cannot advance any further.

Needle 360 is axially secured to female luer connector 380. The female luer connector 380 may be axially movable relative to the housing 341 through a small axial distance, but is restricted from movement beyond a small range of movement by a snap-fit arrangement or other forced configuration as described in the first embodiment. In this arrangement, the needle 360 is forcibly fixed in the housing 341 and is allowed to move only a small axial distance relative to the housing before being stopped from further axial movement. Instead, carrier 350 and head b of second membrane 352 may move axially relative to housing 341 through a majority of the length of the housing.

The first septum 325 and the second septum 352 are formed of an elastic material that may be pierced by the needle 360 as the carrier 350 and the head 352b are pushed deeper into the housing 341. Needle 360 has a side opening 362 that is maintained sealed by second membrane 352 prior to connecting second adapter 340 to first adapter 320, as shown. Needle 360 also has a sharpened tip 364 configured to pass through the head 352b of the second septum 352 and the first septum 325.

During insertion of the first adapter into the second adapter 340, when the first adapter 320 displaces the carrier 350 and the head 352b of the second membrane 352, the collapsible portion 352c of the second membrane 352 collapses under the stored energy in response to the axial load. This causes carrier 350 and head 352b to advance within housing 341 toward bottom flange 352 d. As described in the first embodiment, the needle 360 is moved a small axial distance relative to the housing 341 and then stopped from further axial displacement by a snap fit arrangement or other forced configuration. Once the needle 360 stops further axial movement, the needle tip 364 pierces the second septum 352 until the needle tip emerges from the second septum and immediately passes through the first septum 325 pressed against the second septum. The side opening 362 of the needle 360 also moves from the interior of the second septum 352 into the first septum 325. Continued advancement causes the needle tip 364 and the side opening 362 to pass through the first septum 325 until the needle opening is in fluid communication with the first channel 323 in the first adapter 320. At this stage, the carrier 350 reaches the second position, and the needle 360 forms a fluid channel between the first adapter 320 and the second adapter 340. This substantially coincides with the snap arms 326 snapping over the protrusions 344. At this stage, first adapter 320 may be rotated clockwise relative to second adapter 340 until one of hard stops 347 is encountered. When encountering one of the hard stops 347, the first and second adapters 320, 340 are locked together in a "fluid path open" state, wherein the needle 360 provides a fluid path between the first and second adapters and their respective reservoirs.

As described above, when compressed together, the first diaphragm 325 and the second diaphragm 352 form a dry break coupler. The elastomeric material of the first membrane 325 and the second membrane 352 automatically closes and isolates the space between the needle 360 and the interior of the CSTD 300 so that liquid cannot spill, leak or escape.

After CSTD 300 is used to transfer liquid between the sockets, first adapter 320 remains locked to second adapter 340 by engagement between snap arms 326 and tabs 344. To remove first adapter 320 from second adapter 340, the user may rotate first adapter in a counter-clockwise direction relative to second adapter until another one of hard stops 347 is encountered. At this stage, the snap arms 326 are aligned with the channels 348 through the tabs 344, allowing the snap arms to travel through the channels and facilitating the separation of the first adapter from the second adapter.

When the first and second adapters 320, 340 are locked together, the energy stored in the collapsible middle section 352c creates an axial spring force that secures the first and second adapters together under tension. When the first adapter 320 is rotated to the unlocked position and withdrawn from the second adapter 340, the energy stored in the collapsible middle section 352c is released, creating a spring force that expands the collapsible middle section and pushes the head 352b of the second septum 352 back over the tip 364 of the needle 360. This provides a safety feature that protects the needle tip 364 after the first adapter 320 is removed from the second adapter 340. At any time before, during or after proper use of CSTD 300, needle tip 360 is not exposed to the atmosphere in which it may directly contact the user.

CSTDs according to the present disclosure may have various couplers and attachment structures for connecting each adapter to a reservoir. For example, the female luer connectors 180, 280 and 380 are rotatably mounted about their housings and have threads 182, 282, 382, respectively. The housings 141 and 241 have shields 141c and 241c extending around the luer connectors 180 and 280, respectively. The housing also has a ratchet mechanism 141d, 241d, 341d that includes ramps that cooperatively engage tabs on the female luer connectors 180, 280, and 380, respectively. Threads 182, 282, 382 and ratcheting mechanisms 141d, 241d, 341d allow the male luer connector to be screwed onto the female luer connector in a first direction (e.g., clockwise), but prevent the male luer connector from being unscrewed from the female luer connector in a second direction (e.g., counter-clockwise) opposite the first direction. This may prevent a user from disconnecting the syringe (or other reservoir) from the second adapter after the liquid has been delivered through the device. The threads and ratchet mechanism can have a variety of configurations, including but not limited to those described in applicant's U.S. patent No. 7,857,805 and U.S. patent No. 5,328,474, the contents of both of which are incorporated herein by reference in their entirety.

The housing and shroud according to the present disclosure may be manufactured as separately formed parts. For example, CSTD 100 has a housing 141 and a separately formed shield 141c assembled together. In alternative embodiments, the housing and shield may be manufactured as a unitary component.

Referring to fig. 17-22, a CSTD 100' is shown according to another embodiment, wherein the housing and shield are manufactured as a one-piece component. Features of CSTD 100 'corresponding to features of CSTD 100 are labeled with the same reference number followed by prime symbol ('). For the sake of brevity, some features of CSTD 100' that exist in the same or equivalent form in the previously described embodiments will not be described.

CSTD 100 'has an integral housing 141' that can be injection molded. The shield 141c 'is integrated with the housing 141' as a single unit. This integration reduces the total number of parts and steps required to assemble CSTD 100'. As shown, two cutouts extend on opposite sides of the slot 145'. The cutout provides easier access to the interior of the housing 141' than conventional adapters. Easier access to the interior allows both sides of the device to be more easily sterilized.

Referring to fig. 20, the cstd 100 'has a pair of undercuts 141e' in the inner wall 141a 'of the case 141'. The undercut 141e 'engages with a ledge 151' on the carrier 150 'to secure the carrier in the first position such that the carrier cannot be removed from the housing 141'. As shown in fig. 20, the housing 141 'also has a pair of locking ramps 170' that lockingly engage lugs 151 'on the carrier 150' to lock the carrier in the second position.

Referring to fig. 85-89, a CSTD 1000' is shown according to another embodiment, wherein the housing and shroud are manufactured as a one-piece component. Features of CSTD 1000' corresponding to features of CSTD 100' are labeled with the same reference symbol multiplied by 10 and followed by prime symbol ('). For the sake of brevity, some features of CSTD 1000' that exist in the same or equivalent form in the previously described embodiments will not be described.

CSTD 1000 'has a unitary housing 1410' that can be injection molded. The shield 1410c 'is integrated with the housing 1410' as a single unit. Integration of the shield 1410c ' and housing 1410' reduces the total number of parts and steps required to assemble the CSTD 1000 '.

CSTD 1000' differs from CSTD 100' in the mechanism used to secure carrier 1500' in the first and second positions. Referring to fig. 88 and 89, a housing 1410 'has a pair of first locking windows 1732' extending through the housing 1410 'and a pair of second locking windows 1734' extending through the housing. The first locking windows 1732' lockingly engage a pair of lugs 1510' on the carrier 1500' to secure the carrier in the first position. As shown in fig. 89, the second locking windows 1734' lockingly engage lugs 1510' on the carrier 1500' to secure the carrier in the second position. Lug 1510' is visible from the exterior of CSTD 1000' through first locking window 1732' and second locking window 1734' to provide a visual indicator of the position of carrier 1500' and the operational status of the device.

Referring to fig. 90-92, a CSTD 1000 "is shown according to another embodiment, wherein the housing and shield are manufactured as a one-piece component. Features of CSTD 1000", which correspond to features of CSTD 1000', are labeled with the same reference number followed by two prime symbols ("). For the sake of brevity, some features of CSTD 1000 "that exist in the same or equivalent form in the previously described embodiments will not be described.

CSTD 1000 "has a first adapter 1200" configured to attach to a first fluid reservoir and a second adapter 1400 "configured to attach to a second fluid reservoir. First adapter 1200 "and second adapter 1400" are similar to first adapter 1200' and second adapter 1400' on CSTD 1000', but have different side flanges 1200f "and 1400f" for securing each adapter. Further, first adapter 1200 "has a different connector 1201" for attachment to a vial or other reservoir.

The first adapter 1200 "and the second adapter 1400" may be interconnected in a coupled and locked state to form a closed fluid channel between the first fluid reservoir and the second fluid reservoir. The second adapter 1400 "has a shroud 1410c" integral with a housing 1410 "forming a single unitary body. Housing 1410 "contains a carrier 1500" having a pair of lugs 1510 "that are identical in construction to carrier 1500' shown in fig. 87-89. The carrier 1500 "is slidable in the housing 1410" between a first position and a second position in the same manner as the carrier of the previous embodiments.

Fig. 90 shows the first adapter 1200 "and the second adapter 1400" in an uncoupled or "fully decoupled" state, with the carrier 1500 "in a first position in the housing 1410". Fig. 91 shows the first adapter 1200 "partially inserted into the second adapter 1400", wherein the carrier 1500 "is moved to an intermediate position (not visible) between the first position and the second position. Fig. 92 shows the first adapter 1200 "fully inserted into the second adapter 1400", wherein the carrier 1500 "is secured in the second position, and the first adapter and the second adapter are in a coupled and locked state, or" fully connected "state.

Housing 1410 "has a pair of first locking windows 1732" extending through housing 1410 "and a second locking window 1734" opening into opposite sides of the housing. As shown in fig. 90, the first locking windows 1732 "lockingly engage lugs 1510" on the carrier 1500 "to secure the carrier in the first position. As shown in fig. 92, the second locking windows 1734 "lockingly engage lugs 1510" on the carrier 1500 "to secure the carrier in the second position. The lugs 1510 "are visible from the exterior of the CSTD 1000" through the first locking window 1732 "and the second locking window 1734" to provide a visual indicator of the position of the carrier 1500 "and whether the adapter is in a fully disconnected or fully connected state. Lugs 1510 "are visible only through housing 1410" when the carrier is in either the first position or the second position. Thus, when CSTD 1000 "is in a fully connected state or a fully disconnected state, lugs 1510" can only be seen through housing 1410 ". To enhance the visibility of lug 1510", housing 1410" can be made in one color or shade and lug 1510 "can be made in a contrasting color or shade so that a user can easily see when CSTD 1000" is in a fully disconnected or fully connected state.

Referring to fig. 93-95, a CSTD 1000' "is shown according to another embodiment wherein the housing and shield are manufactured as a one-piece component. Features of CSTD 1000 '"corresponding to features of CSTD 1000" are labeled with the same reference number followed by three prime symbols ("'). For the sake of brevity, some features of CSTD 1000' "that exist in the same or equivalent form in the previously described embodiments will not be described.

CSTD 1000 '"is similar or identical in many respects to CSTD 1000", but has a first locking window 1732' "that is surrounded by a frame of material on the front side of the device as shown.

Turning back to fig. 23-25, CSTD 100 "is shown according to another embodiment. CSTD 100 "has a first adapter 120" configured to attach to a first fluid reservoir and a second adapter 140 "configured to attach to a second fluid reservoir. For example, the first adapter 120 "may be connected to a vial, bag, or patient line. The second adapter 140 "has a female luer connector 180" that can be connected to any male luer connector on a syringe or fluid delivery device, such as a pump. Once first adapter 120 "and second adapter 140" are attached to the first fluid reservoir and second fluid reservoir, respectively, and interconnected to one another in the coupled state shown in FIG. 23, CSTD 100 "forms a closed fluid channel between the first fluid reservoir and the second fluid reservoir. The closed fluid channel is isolated from the external environment, preventing contaminants from flowing into the system and preventing harmful vapors from being released from the system.

When the first adapter and the second adapter are axially aligned and/or connected, CSTD 100 "has a longitudinal axis X extending through the central axis of first adapter 120" and the central axis of second adapter 140 ". The first adapter 120 "has a generally rectangular body 121". The second adapter 140 "has a generally rectangular socket or housing 141". The housing 141 "is adapted to receive the body 121" of the first adapter 120 "in a guided manner such that the two adapters are axially aligned and centered during mating. The housing 141 "has a hollow interior 143" and a slot 145 "adapted to receive the first adapter 120" during mating. As shown, two cutouts extend on opposite sides of the slot 145 ". The cutout provides easier access to the interior of the housing 141 "than conventional adapters. Easier access to the interior allows both sides of the device to be more easily sterilized.

Fig. 26 and 27 show cross-sections of the first adapter 120 "and the second adapter 140" before being coupled together. The first adapter 120 "has a first channel 126" and a first membrane 128 "made of an elastic material. The first channel 126 "has a first channel end 126a" and a second channel end 126b "opposite the first channel end. The first channel end 126a "defines a first opening 126c" and the second channel end 126b "defines a second opening 126d". The first channel 126 "forms a cylindrical chamber or seat 129" at the second channel end 126b ". The first diaphragm 128 "is received in the seat 129" to seal the second channel end 126b ". A portion of the first diaphragm 128 "extends axially from the second opening 126d" forming a first protrusion 128g ".

The second adapter 140 "has a second channel 146" and a second membrane 148 "made of an elastic material. The second channel 146 "has a first channel end 146a" and a second channel end 146b "opposite the first channel end. The first channel end 146a "defines a first opening 146c" and the second channel end 146b "defines a second opening 146d". The first channel 146 "forms a cylindrical cavity or seat 149" at the second channel end 146b ". The second diaphragm 148 "is received in the seat 149" to seal the second channel end 146b ". A portion of the second membrane 148 "extends axially from the seat 149" forming a second protrusion 148g ". The second projection 148g "is configured to abut and be deformed by the first projection 128g" and vice versa to form a dry break coupler.

The second membrane 148 "is contained in a carrier 150" carrying the second membrane. The carrier 150 "is configured to slide axially within the housing 141" between a first position and a second position. Fig. 26 and 27 show the carrier 150 "in a first position. The carrier 150 "has two flexible clips 152" made of a resiliently flexible material. In the fully relaxed state, as shown in fig. 25, the clamp 152 "extends radially outward in a non-parallel arrangement. As shown in fig. 26, when the carrier 150 "is assembled within the housing 141" in the first position, the clips 152 "flex slightly inward such that they extend parallel to one another. In this parallel state, the clamp 152 flexes slightly inward "in a relatively relaxed state", with some energy stored in the clamp.

Each clip 152 "has a clip end 153" with a rounded protrusion 154 "extending radially outwardly from the clip, and a pointed tip 155" extending radially inwardly from the clip. When the carrier is in the first position, each rounded protrusion 154 "rests or supports against a tapered platform 147" formed in the housing 141 ". The clamp 152 "engages the platform 147" to hold the carrier in the first position, wherein the second membrane 148 "is positioned adjacent to the slot 145".

The first adapter 120 "is connected to the second adapter 140" by inserting the body 121 "into the slot 145" until the first membrane 128 "contacts the second membrane 148". Once first membrane 128 "abuts second membrane 148", movement of carrier 150 "from the first position is prevented by engagement between clamp 152" and platform 147". This resistance is overcome by applying a manual force to the first adapter 120 "in an axial direction toward the second diaphragm 148" until the manual force exceeds the resistance.

The first adapter 120 "has an outer wall 129a". When the first adapter 120 "is moved into the hollow interior 143" through the slot 145", the outer wall 129a" temporarily engages and slides against the prongs 155 "of the clip 152". This holds the clamp 152 "in its rest position against the platform 147 and prevents the clamp from flexing further inward. The outer wall 129 "tapers inwardly at the transition 123". In this arrangement, the first adapter 120 "can be inserted into the second adapter 140" such that the outer wall 129a "travels between the clips 152" and slides past the prongs 155".

Once the outer wall 129a "travels past the prongs 155", the prongs slide over the outer wall and reach the transition 123". In this position, the outer wall 129a "no longer prevents the clip 152" from flexing inwardly because the narrower dimension at the transition 123 "provides a gap that allows the clip to flex inwardly. The hollow interior 143 "of the second adapter 140" narrows as it extends inwardly from the platform 147". Thus, further advancement of the first adapter 120 "into the second adapter 140" causes the clip ends 153 to flex inwardly such that they no longer bear against the platform 147". In this position, the carrier 150 "is free to move from a first position to a second position in the housing 141". Fig. 28 and 29 show the first adapter 120 "fully inserted into the second adapter 140", wherein the carrier 150 "is moved to the second position and the clip 152" is deflected inwardly.

The hollow interior 143 "of the second adapter 140" has a wider section 143a "at the slot 145", which is shown above the platform 147". The hollow interior 143 "transitions into a narrower section 143b" below the platform. When the carrier 150 "advances from the first position to the second position, the circular protrusion 154" on the clamp 152 "slides and bears against the inner wall 141a" of the housing 141'. This abutment between the rounded protrusion 154 "and the inner wall 141a" causes the clip 152 "to flex further inwardly into a more flexed state upon entering the narrower section 143b" of the hollow interior 143 ". The prongs 155 "of the clip 152" are pushed inwardly and rest against the protrusions 125 "on the outer wall 129a" of the first adapter 120 ".

The second adapter 140 "houses the needle 160". The needle 160 "is axially fixed in the housing 141" of the second adapter 140", while the carrier 150" and the second septum 148 "are axially movable relative to the housing. First membrane 128 "and second membrane 148" are formed of an elastic material that can be pierced by needle 160 "when carrier 150" is pushed toward the second position. The needle 160 "has a side opening 162" that remains sealed within the carrier 150 "prior to coupling the second adapter 140" to the first adapter 120 ". The side opening 162 "is sealed within the narrowed section 146e" of the second channel 146 ". The narrowed section 146e "is sealed at a first end by a second membrane 148" and at a second end by a third membrane 158 ".

As the first adapter 120 "advances into the housing 141", the first septum 128 "pushes against the second septum 148" and moves the second septum and carrier 150 "downward in the housing (or toward the female luer connector 180"). The second membrane 148 "and carrier 150" move downward over the needle 160 "which remains stationary in the housing 141". Needle 160 "has a sharpened tip 164" configured to pass through first septum 128 "and second septum 148". As carrier 150 "moves downward over needle 160", needle tip 164 "passes through second septum 148" and immediately into first septum 128". During this movement, the side opening 162 "of the needle 160" travels through the second septum 148 "and immediately into the first septum 128". Accordingly, side opening 162 "remains isolated from other interior regions of CSTD 100" after emerging from second membrane 148 "and traveling into first membrane 128".

As carrier 150 "moves down over needle 160", side opening 162 "moves through three sealing positions relative to the other components. In the first sealing position, as shown in fig. 26 and 27, the side opening 162 "is sealed between the second membrane 148" and the third membrane 158 ". In the second sealing position, the side opening 162 "is sealed within the second membrane 148". In the third sealing position, the side opening 162 "is sealed within the first diaphragm 128". Once the carrier 150 "bottoms out in the receptacle, the first membrane 128 is pushed downwardly through the side opening 162" such that the side opening 162 "emerges from the first membrane and is exposed in the first channel 126" of the first adapter 120 ". In this state shown in fig. 28 and 29, the side opening 162 "forms a communication fluid path between the first adapter 120", the second adapter 140", and the reservoir to which the adapter is connected.

When the carrier 150 "reaches the second position, the first protrusion 128g" on the first membrane 128 "abuts the second protrusion 148g" on the second membrane 148 "to form a dry-break coupling. The elastomeric material of first membrane 128 "and second membrane 148" compresses together automatically closing and isolating the space between needle opening 162 "and the interior space in CSTD 100" so that liquid and vapor cannot escape, leak or escape from the device.

Returning to fig. 24, the housing 141 "of the second adapter 140" has a front wall 141b ". Front wall 141b "defines a longitudinal slot 141c" extending from slot 145 "to female luer connector 180". The locking arm 142 "is pivotally mounted in the slot 141c" and extends longitudinally within the front wall 141b ". The locking arm 142 "is pivotally connected to the front wall 141b" by a pair of elastic hinges 141d ". In this arrangement, the locking arm 142 "is pivotable relative to the front wall 141b" between the locked and released positions shown in fig. 5.

The locking arm 142 "has a first end forming a button 142a" and a second end opposite the first end forming a pawl 142b ". When the locking arm 142 "is in the locked position, the button 142a" protrudes radially outward from the front wall 141b ". When the locking arm 142 "is in the locked position, the pawl 142b" protrudes radially inward from the front wall 141b "and into the housing 141". The pawl 142b "may pivot in a radially outward direction relative to the front wall 141b" in response to contact with the carrier 150 ". As will be explained, the pawl 142b "may also pivot in a radially outward direction relative to the front wall 141b" in response to a force applied to the button 142a ".

Pawl 142b "has a beveled surface 142c" oriented at an acute angle relative to the longitudinal axis X of CSTD 100 ". The pawl 142b "also has an abutment surface 142d" extending perpendicular to the longitudinal axis X. Carrier 150 "has locking holes 151" above the bottommost edge 159 ". The bottommost edge 159 "is configured to slidingly engage the ramp surface 142c" when the carrier 150 "is moved to the second position. Engagement between the bottommost edge 159 "and the ramped surface 142c" causes the locking arm 142 "to pivot radially outward using energy stored in the resilient hinge 141 d". The bottommost edge 159 "slides over the ramped surface 142c" until the pawl 142b "is radially aligned with the locking hole 151". At this time, the carrier 150 "bottoms out in the housing 141" to the second position shown in fig. 29. In this position, the bottommost edge 159 "no longer bears against the pawl 142b", allowing the locking arm 142 "to snap radially inward into its relaxed position with the pawl extending into the locking hole 151". The abutment surface 142d "engages the abutment edge 151a" in the locking hole 151". This engagement prevents carrier 150 "from moving back to the first position. As previously described, the first adapter 120 "is interlocked with the carrier 150" by the clamp 152 ". Thus, the engagement between the abutment surface 142d "and the abutment edge 151a" also prevents the first adapter 120 "from being withdrawn from the second adapter 140". This locks CSTD 100 "in a" fluid path open "state, wherein needle 160" provides a fluid path between first adapter 120 "and second adapter 140" and their respective reservoirs.

After fluid is delivered through CSTD 100", first adapter 120" remains locked within second adapter 140 "by engagement between abutment surface 142d" and abutment edge 151a "and by engagement between clamp 152" and projection 125 ". The first adapter 120 "may be released from the second adapter 140" by applying a radially inward force F to the button 142a ". The direction of force F is indicated by the arrow in fig. 29. When the button 142a "is pressed radially inward, the pawl 142b" pivots radially outward and out of the locking hole 151", wherein energy is stored in the hinge 141 d". At this stage, the abutment surface 142d "on the pawl 142b" no longer prevents the carrier 150 "from moving back from the second position to the first position. It no longer prevents the first adapter 120 from moving back toward the slot 145 ". Thus, by pressing button 142a "inward to release carrier 150" and pulling the first adapter out of hollow interior and slot 145", the first adapter 120" can be removed from hollow interior 143 "of second adapter 140".

When the first adapter 120 "is withdrawn from the hollow interior 143", the protruding portion 125 "on the first adapter remains engaged with the underside of the clamp end 153". This engagement causes carrier 150 "to be pulled or pulled back to the first position as first adapter 120" is withdrawn from housing 141". When the carrier 150 "reaches the first position, the clamp end 153" exits the narrower section 143b "of the hollow interior 143" and enters the wider section 143a ". This causes the clamp ends 153 "to snap outwardly to the relatively relaxed state shown in fig. 26. The outward movement of the clip end 153 "releases the clip end from the projection 125" on the first adapter 120". Thus, the tab 125 "is released from the clamp 152" allowing the first adapter 120 "to be pulled completely out of the housing 141 and separated from the second adapter 140". Carrier 150 "is prevented from being pulled out of housing 141" by flange 159a "which extends radially outwardly from bottommost edge 159". The flange 159a "forms a stop that engages an undercut 141e" in the inner wall 141a "of the housing 141" preventing removal of the carrier 150 "from the housing.

CSTDs according to the present disclosure may include one or more alignment structures that maintain the components in proper axial and radial alignment as the components move relative to one another. For example, CSTD 100 "includes longitudinal channels 141f" along the inner wall 141a "of housing 141" as shown in fig. 30. The channel 141f "is adapted to receive a longitudinally extending rail 127" on the first adapter 120 "to maintain proper alignment between the first adapter and the housing 141".

The female luer connector 180 "is connected with the housing 141" in a fixed arrangement with tabs 181 ". In alternative embodiments, the female luer connector may be rotatably mounted to the housing with a ratchet mechanism. The ratchet mechanism may be configured to allow the male luer connector to be screwed onto the female luer connector in a first direction (e.g., clockwise), but to prevent the male luer connector from being unscrewed from the female luer connector in a second direction (e.g., counter-clockwise) opposite the first direction. This provides a safety feature that prevents a user from disconnecting the syringe (or other reservoir) from the second adapter after the liquid has been delivered through the device. The threads and ratchet mechanism can have a variety of configurations, including but not limited to those described in U.S. patent No. 7,857,805 and U.S. patent No. 5,328,474, the contents of both of which are incorporated herein by reference in their entirety.

Referring to fig. 31-33, a CSTD 100' "is shown according to another embodiment. CSTD 100 ' "has a first adapter 120 '" configured to attach to a first fluid reservoir and a second adapter 140 ' "configured to attach to a second fluid reservoir. For example, the first adapter 120' "may be connected to a vial, bag, or patient line. The second adapter 140 '"has a female luer connector 180'" that can be connected to any male luer connector on a syringe or fluid delivery device, such as a pump. Once the first adapter 120 ' "and the second adapter 140 '" are attached to the first fluid reservoir and the second fluid reservoir, respectively, and are interconnected to each other in the coupled state shown in fig. 31, the CSTD 100 ' "forms a closed fluid channel between the first fluid reservoir and the second fluid reservoir. The closed fluid channel is isolated from the external environment, preventing contaminants from flowing into the system and preventing harmful vapors from being released from the system.

When the first adapter and the second adapter are axially aligned and/or connected, CSTD 100 ' "has a longitudinal axis X extending through the central axis of the first adapter 120 '" and the central axis of the second adapter 140 ' ". The first adapter 120 '"has a generally rectangular body 121'". The second adapter 140 '"has a generally rectangular receptacle or housing 141'". The body 121 ' "of the first adapter 120 '" is adapted to receive the housing 141 ' "in a guided manner such that the two adapters are axially aligned and centered during mating. As will be explained, the housing 141 '"has a hollow interior 143'" and a slot 145 '"adapted to receive the interior of the first adapter 120'" during mating. As shown, two cutouts extend on opposite sides of the slot 145' ". The cutout provides easier access to the interior of the housing 141' "than conventional adapters. Easier access to the interior allows both sides of the device to be more easily sterilized.

Fig. 34 shows a cross section of the first adapter 120 '"and the second adapter 140'" prior to being coupled together. The first adapter 120 ' "has a first passageway 126 '" and a first membrane 128 ' "made of an elastomeric material. The first channel 126 ' "has a first channel end 126a '" and a second channel end 126b ' "opposite the first channel end. The first channel end 126a '"defines a first opening 126 c'" and the second channel end 126b '"defines a second opening 126 d'". The first channel 126 ' "forms a cylindrical chamber or seat 129 '" at the second channel end 126b ' ". The first diaphragm 128 ' "is received in the seat 129 '" to seal the second channel end 126b ' ". A portion of the first diaphragm 128 ' "extends axially from the second opening 126d '" forming a first protrusion 128g ' ".

The second adapter 140 ' "has a second channel 146 '" and a second membrane 148 ' "made of an elastomeric material. The second channel 146 ' "has a first channel end 146a '" and a second channel end 146b ' "opposite the first channel end. The first channel end 146a '"defines a first opening 146 c'" and the second channel end 146b '"defines a second opening 146 d'". The first channel 146 ' "forms a cylindrical cavity or seat 149 '" at the second channel end 146b ' ". The second diaphragm 148 ' "is received in the seat 149 '" to seal the second channel end 146b ' ". A portion of the second membrane 148 ' "extends axially from the seat 149 '" forming a second protrusion 148g ' ". The second projection 148g '"is configured to abut and be deformed by the first projection 128 g'" and vice versa to form a dry break coupler.

The second membrane 148 '"is contained within a carrier 150'" carrying the second membrane. The carrier 150 '"is configured to slide axially within the housing 141'" between a first position and a second position. Fig. 34 shows the carrier 150' "in a first position. The carrier 150 '"has two flexible clips 152'" made of a resiliently flexible material. In the fully relaxed state, the clamps 152' "extend parallel to one another.

Each clip 152 '"has a clip end 153'" having a rounded protrusion 154 '"extending radially outwardly from the clip and a tip 155'" extending radially inwardly from the clip. When the carrier is in the first position, each rounded protrusion 154 ' "rests or bears against a tapered platform 147 '" formed in the housing 141 ' ". The clamp 152 '"engages the platform 147'" to hold the carrier in the first position wherein the second membrane 148 '"is positioned adjacent the slot 145'".

The first adapter 120 '"is connected to the second adapter 140'" by inserting the housing 141 '"of the second adapter into the body 121'" of the first adapter. The housing 141 '"is inserted into the body 121'" until the first diaphragm 128 '"contacts the second diaphragm 148'". Once the first membrane 128 ' "abuts the second membrane 148 '", movement of the carrier 150 ' "from the first position is prevented by engagement between the clamp 152 '" and the platform 147 ' ". This resistance is overcome by applying manual force to the first adapter 120 '"in an axial direction toward the second diaphragm 148'" until the manual force exceeds the resistance.

The first adapter 120 '"has an outer wall 129 a'". As the outer wall moves into the hollow interior 143 "through the slot 145 '", the outer wall 129 a' "temporarily engages and slides against the prongs 155 '" of the clip 152' ". This holds the clamp 152 '"in its rest position against the platform 147'" and prevents the clamp from flexing further inward. In this arrangement, the outer wall 129a ' "and the first septum 128 '" can be inserted into the hollow interior 143 ' "of the second adapter 140 '" and advanced through the tip 155 ' ".

Once the outer wall 129a ' "travels past the tip 155 '", the tip slides over the outer wall and reaches the transition 123 ' "where the outer wall tapers radially inward. When the arrow 155 '"reaches this position, the outer wall 129 a'" no longer prevents inward deflection of the clip 152 '"because the narrower dimension at the transition 123'" provides a gap that allows inward deflection of the clip. The hollow interior 143 ' "of the second adapter 140 '" narrows as it extends inwardly from the platform 147 ' ". Thus, further advancement of the outer wall 129a ' "and the first diaphragm 128 '" into the housing 141 ' "causes the clip end 153 '" to flex inwardly such that they no longer bear against the platform 147 ' ". In this position, the carrier 150 '"is free to move from a first position to a second position in the housing 141'". Fig. 35 shows the outer wall 129a ' "and the first membrane 128 '" fully inserted into the housing 141 ' "with the carrier 150 '" moved to the second position and the clip 152 ' "flexed inwardly.

Referring to fig. 34 and 35, the hollow interior 143 "of the second adapter 140 '" has a wider section 143a ' "at the slot 145", which is shown above the platform 147 ' ". The hollow interior 143 '"transitions into a narrower section 143 b'" below the platform. As the carrier 150 ' "advances from the first position to the second position, the rounded protrusion 154 '" on the clamp 152 ' "slides and bears against the inner wall 141a '" of the housing 141 ' ". This abutment between the rounded protrusion 154 '"and the inner wall 141 a'" causes the clip 152 '"to flex inwardly into a deflected state upon entering the narrower section 143 b'" and store energy. The prongs 155 ' "of the clip 152 '" are pushed inwardly and rest against the projections 125 ' "on the outer wall 129a '" of the first adapter 120 ' ".

The second adapter 140 '"houses a needle 160'". The needle 160 ' "is axially fixed in the housing 141 '" of the second adapter 140 ' "and the carrier 150 '" and the second septum 148 ' "are axially movable relative to the housing. First membrane 128 '"and second membrane 148'" are formed of an elastomeric material that can be pierced by needle 160 '"when carrier 150'" is pushed toward the second position. The needle 160 ' "has a side opening 162 '" that remains sealed within the carrier 150 ' "prior to coupling the second adapter 140 '" to the first adapter 120 ' ". The side opening 162 ' "is sealed within the narrowed section 146e '" of the second channel 146 ' ". The narrowed section 146e ' "is sealed at a first end by a second membrane 148 '" and at a second end by a third membrane 158 ' ".

As the outer wall 129a '"and the first septum 128'" are advanced into the housing 141 '", the first septum pushes against the second septum 148'" and moves the second septum and carrier 150 '"downward in the housing (or toward the female luer connector 180'"). The second septum 148 '"and the carrier 150'" move downward over the needle 160 '"which remains stationary within the housing 141'". The needle 160 '"has a sharpened tip 164'" configured to pass through the first septum 128 '"and the second septum 148'". As carrier 150 ' "moves downward over needle 160 '", needle tip 164 ' "passes through second septum 148 '" and immediately into first septum 128 ' ". During this movement, the side opening 162 '"of the needle 160'" travels through the second septum 148 '"and immediately into the first septum 128'". Accordingly, side opening 162 '"remains isolated from other interior regions of CSTD 100'" after emerging from second membrane 148 '"and traveling into first membrane 128'".

As carrier 150 ' "moves downwardly over needle 160 '", side opening 162 ' "moves relative to the other components through three sealing positions. In the first sealed position, as shown in fig. 34, the side opening 162 ' "is sealed between the second diaphragm 148 '" and the third diaphragm 158 ' ". In the second sealed position, the side opening 162 '"is sealed within the second diaphragm 148'". In the third sealing position, the side opening 162 '"is sealed within the first diaphragm 128'". Once the carrier 150 '"bottoms out in the receptacle, the first membrane 128'" is pushed downwardly through the side opening 162 '"such that the side opening 162'" is exposed from the first membrane and is exposed in the first channel 126 '"of the first adapter 120'". In this state shown in fig. 35, the side opening 162 ' "forms a communication fluid path between the first adapter 120 '", the second adapter 140 ' "and the reservoir to which the adapter is connected.

When the carrier 150 ' "reaches the second position, the first protrusion 128g '" on the first membrane 128 ' "abuts the second protrusion 148g '" on the second membrane 148 ' "to form a dry-break coupling. The elastomeric material of first membrane 128 '"and second membrane 148'" compress together automatically closing and isolating the space between needle opening 162 '"and the interior space in CSTD 100'" so that liquid and vapor cannot escape, leak or escape from the device.

Returning to fig. 32, the body 121 ' "of the first adapter 120 '" has a pair of sidewalls 121a ' ". Each sidewall 121a '"defines a longitudinal slot 121 b'". A locking arm 122 ' "is pivotally mounted in each slot 121b '" and extends longitudinally within each sidewall 121a ' ". Each locking arm 122 ' "is pivotally connected to its respective side wall 121a '" by a pair of resilient hinges 121c ' ". In this arrangement, each locking arm 122 '"is pivotable relative to its respective front wall 121 a'" between a locking position shown in fig. 35 and a release position. Each locking arm 122 ' "has a first end 122a '" forming a button 123 ' "and a second end 122b '" opposite the first end defining a locking aperture 124 ' ". Each locking aperture 124 ' "is configured to cooperatively engage a section of the second adapter 140 '" to releasably lock the first adapter 120 ' "to the second adapter.

Referring again to fig. 32, the second adapter 140 ' "has two locking ramps 142 '" that project radially outwardly from the exterior of the housing 141 ' ". Each locking ramp 142 '"is configured to protrude through one of the locking holes 124'" on the first adapter 120 '"to releasably lock the second adapter 140'" to the first adapter. Each locking ramp 142 '"has a leading end 142 a'", a trailing end 142b '"and a ramp 142 c'" extending between the leading end and the trailing end. The beveled surface 142c ' "has a straight section 142d '" parallel to the longitudinal axis X and adjacent the front end 142a ' ". The beveled surface 142 '"also has a curved section 142 e'" extending between the straight section 142d '"and the trailing end 142 b'". The curved section 142e ' "has a compound curvature defining a concave portion 142f '" and a convex portion 142g ' ".

Referring to fig. 34, each locking arm 122 '"has a radially inwardly facing sliding surface 122 c'". Each sliding surface 122c ' "has a rounded convex bearing surface 122d '" at the second end 122b ' "of the locking arm. Support surface 122d '"is configured to slidingly engage curved section 142 e'" of beveled surface 142c '"after first membrane 128'" begins to move second membrane 148 '"and carrier 150'" toward the second position. When the housing 141 ' "initially enters the body 121 '" of the first adapter 120 ' ", the bearing surface 122d '" on the locking arm 122 ' "slides along the straight section 142d '" of the locking ramp 142 ' ". The locking arm 122' "maintains the same general orientation during this sliding engagement. As the housing 141 ' "is advanced further into the body 121 '", the bearing surface 122d ' "eventually reaches and slides along the curved section 142e '" on the beveled surface 142c ' ". The sloped geometry of curved section 142e '"exerts a radially outward force on bearing surface 122 d'" causing second end 12b '"of locking arm 122'" to pivot radially outward. When the locking arm 122 pivots through the side wall 121a '", energy is stored in the elastic hinge 121 c'".

The housing 141 '"is advanced into the body 121'" until the locking slope 142 '"is aligned with the locking hole 124'" in the radial direction. At this time, the trailing end 142b ' "of the locking ramp 142 '" travels past the bearing surface 122d ' ". The bearing surface 122d '"is no longer bearing against the locking ramp 142'" allowing the locking arms 122 '"to release the energy stored in the resilient hinge 121 c'" and spring back radially inward into a more relaxed state in their locked position. As shown in fig. 35, the locking arm 122 ' "is returned to the locked position wherein the locking ramp 142 '" is clamped within the locking aperture 124 ' ". This occurs at or about the same time that the side opening 162 ' "of the needle 160 '" is fully exposed from the first septum 128 ' "and into the first passageway 126 '" in the first adapter 120 ' ".

When the locking arm 122 ' "snaps inwardly to the locked position, the trailing end 142b '" of the locking ramp 142 ' "is positioned adjacent the abutment surface 122e '" within the locking hole 124 ' ". The abutment surface 122e '"forms an axial stop or obstruction that engages the trailing end 122 b'" of the locking ramp. Thus, when the locking arm 142 '"is in the locked position, the abutment surface 122 e'" prevents the housing 141 '"from being flipped from the body 121'". This locks CSTD 100 '"in a" fluid path open "state wherein needle 160'" provides a fluid path between first adapter 120 '"and second adapter 140'" and their respective reservoirs.

After fluid is delivered through CSTD 100 '", the housing 141'" of the second adapter remains locked within the first adapter 120 '"by engagement between the abutment surface 122 e'" and the trailing end 142b '"of the locking ramp 142'". By applying a radially inward force F to each button 123 ' ", the housing 141 '" can be released from the first adapter 120 ' ". The direction of the force F' "is indicated by an arrow in fig. 35. When the button 123 '"is pressed radially inwards, the second end 12 b'" of the locking arm 122 '"is pivoted radially outwards and energy is stored again in the hinge 121 c'". The button 123 '"is pressed radially inwardly until the abutment surface 122 e'" is pivoted outwardly sufficiently far to clear the trailing end 142b '"of the locking ramp 142'". At this stage, the locking ramp 142b ' "is no longer enclosed by the locking hole 124 '" and the abutment surface 122e ' "is no longer impeding the axial movement of the locking ramp 142 '" relative to the first adapter 120 ' ". Thus, the second adapter 140 ' "can be disconnected from the first adapter 120 '" by pressing the button 123 ' "radially inward to release the locking ramp 142 '" and pulling the housing 141 ' "out of the first adapter.

When the housing 141 '"is withdrawn from the first adapter 120'", the protruding portion 125 '"on the first adapter remains engaged with the underside of the clip end 153'" which is still curved inwardly. This engagement causes the carrier 150 ' "to be pulled or pulled back to the first position as the housing 141 '" is withdrawn from the first adapter 120 ' ". When the carrier 150 ' "reaches the first position, the clamp end 153 '" exits the narrower section 143b ' "of the hollow interior 143 '" and enters the wider section 143a ' ". This causes the clip ends 153' "to snap outwardly to the relatively relaxed state shown in fig. 34. The outward movement of the clip end 153 ' "releases the clip end from the projection 125 '" on the first adapter 120 ' ". Thus, the protruding portion 125 '"is released from the clamp 152'" allowing the outer wall 129a '"and the first membrane 128'" to be separated from the carrier 150 '"and pulled from the housing 141'".

The carrier 150 ' "is prevented from being pulled out of the housing 141 '" by a pair of end walls 141b ' "extending radially inwardly. The end wall 141b ' "defines a narrow opening 145a '" at the slot 145 ' ". When the carrier 150 ' "is in the first position, the width of the openings 145a '" is less than the spacing between the rounded protrusions 154 ' ". In this way, the end wall 141b '"forms a stop that engages the rounded protrusion 154'" to prevent removal of the carrier 150 '"from the housing 141'".

CSTDs according to the present disclosure may include one or more alignment structures that maintain the components in proper axial and radial alignment as the components move relative to one another. For example, the CSTD 100 '"includes longitudinal ribs 141 f'" along the inner wall 141a '"of the housing 141'" as shown in fig. 36. The rib 141f '"is configured to abut a longitudinally extending recess or groove 157'" on the carrier 150 '"to maintain proper alignment between the carrier and the housing 141'".

The female luer connector 180 ' "is rotatably mounted to the housing 141' by a ratchet mechanism 170 '" the elements of which are shown in fig. 33-36. As the female luer connector 180 ' "rotates relative to the housing 141 '", the flange 182 ' "on the top end of the female luer connector 180 '" is configured to slidingly engage the ramped surface of the ratchet 170 ' ". The beveled surface 172 ' "allows the flange 182 '" and thus the female luer connector 180 ' "to rotate in one direction but not in the opposite direction. The female luer connector 180 '"has threads 184'" at its bottom end that are configured to mate with threads on the male luer connector. In this arrangement, the ratchet mechanism 170 '"is configured to allow the male luer connector to be screwed onto the female luer connector 180'" in a first direction (e.g., clockwise), but to prevent the male luer connector from being unscrewed from the female luer connector in a second direction (e.g., counter-clockwise) opposite the first direction. This provides a safety feature that prevents a user from disconnecting the syringe (or other reservoir) from the second adapter after the liquid has been delivered through the device. The threads and ratchet mechanism can have a variety of configurations, including but not limited to those described in U.S. patent No. 7,857,805 and U.S. patent No. 5,328,474, the contents of both of which are incorporated herein by reference in their entirety.

Referring to fig. 37 and 38, a CSTD 100"", according to another embodiment, is shown. CSTD 100"" has a first adapter and a second adapter configured to connect a vial with another fluid reservoir. This type of CSTD is referred to herein as a "vial adapter". CSTD 100 "includes a first adapter referred to as" vial spike "120" and a second adapter referred to as a base or "vial clamp" 190 ". CSTD 100"" has a longitudinal axis Y "" that runs through the central portions of vial spike 120"" and vial clamp 190 "". Vial spike 120"" has a proximal end 122"" forming a first connector 123"" configured to be fluidly connected to a first fluid reservoir, such as a syringe. Vial spike 120"" also has a distal end 124"" forming a second connector 125"" configured to be fluidly connected to a second fluid reservoir, such as a vial. Once the vial spike 120"" is connected in fluid communication with the first fluid reservoir and the second fluid reservoir, respectively, the vial spike forms a closed fluid path between the first fluid reservoir and the second fluid reservoir. Such a closed fluid channel, also referred to herein as a "transfer line", allows liquid to be transferred between the first fluid reservoir and the second fluid reservoir in a sealed manner, thereby preventing release of the harmful drug into the environment.

A vial spike according to the present disclosure may have various fluid connectors at the proximal and distal ends. In this embodiment, the first connector 123"" is a dry break coupler 126"", which prevents the release of liquid or vapor from the CSTD during coupling or uncoupling of the vial spike to the first fluid reservoir. The dry break coupler 126"" has a cylindrical body 127"" defining a fluid passage 127a "". The diaphragm 128"" is mounted in the fluid passage 127a "" within the cylindrical body 127"". The cylindrical body 127"" has external threads 129"" configured to mate with internal threads on a syringe or other fluid reservoir.

The second connector 125"" is a spike connector 130"" having a cylindrical profile 132"" and a spike 134 "". As will be explained, the spike connector 130"" has separate fluid passages that carry liquid and gas through the CSTD.

Referring to fig. 39-41, vial spike 120"" has a three-part housing 140"" that forms a passageway for the flow of liquids and gases within CSTD 100 "". The housing 140"" includes a first housing portion 142"" that is adjacent to and fluidly connected with the dry-break coupler 126 "". The housing 140"" also includes a second housing portion 144"" that is adjacent to and fluidly connected to the spike connector 130"". Further, the housing 140"" includes a third housing portion or shell 146"" attached to one side of the first housing portion 142 "".

The first housing portion 142"" has a first cover 143"" opposite the dry break coupler 126 "". The second housing portion 144"" has a second cover 145"" opposite the spike connector 130 "". The second cover 145"" is configured to connect with the first cover 143"" to join the first housing portion 142"" and the second housing portion 144"" together. The first cover 143"" and the second cover 145"" are shaped to form a narrow gap, void or space 141"" between the first housing portion 142"" and the second housing portion 144"". An annular lip 147"" extends around the perimeter of the first cover 143"" and protrudes from the first housing portion 142 "". The annular wall portion 148"" extends around the periphery of the second cover 145"" forming a receptacle slightly larger in size than the annular lip 147 "". The annular wall portion 148"" is adapted to receive the annular lip portion 147"" to join the first housing portion 142"" to the second housing portion 144"" in a mating and sealing arrangement.

Referring to fig. 41-43, the first cover 143"" has a dividing wall 149"", as shown, that spans the center of the annular lip portion 147 "". When the first cover 143"" is mated with the second cover 145"" the annular wall portion 148"" and the dividing wall 149"" form two separate chambers within the first and second covers. The first chamber 152"" is formed on a first side of the dividing wall 149"" and the second chamber 154"" is formed on a second side of the dividing wall opposite the first side.

First cover 143"" and second cover 145"" are connected to each other such that they completely enclose first chamber 152"" and second chamber 154"", and isolate the chambers from the exterior of vial spike 120"", in a fluid-tight manner. Furthermore, the first cover 143"" and the second cover 145"" are connected to each other, sealing the first chamber 152"" from the second chamber 154"" in a fluid tight manner, and vice versa. In this regard, the first cap 143"" can be joined to the second cap 145"" using any suitable method that seals the chambers from the exterior of the vial spike 120"" and from each other. Suitable methods for establishing such a sealing arrangement include welding techniques such as ultrasonic welding, hot plate welding and laser welding. Suitable methods for establishing the sealing arrangement also include overmolding and gluing.

The spike connector 130"" has a first channel 136"" and a second channel 138"", which extends parallel to the first channel. When vial spike 120"" is fully assembled, first passageway 136"" is in fluid connection with first chamber 152"" but not with second chamber 154"" thereof. Further, the second channel 138"" is fluidly connected to the second chamber 154"", but not to the first chamber 152"". The first channel 136"" extends the entire length of the spike connector 130"" and exits the spike 134"" in which the first opening 137"" is formed. The second fluid channel 138"" also extends the entire length of the spike connector 130"" and exits the arrow 134"" in which the second opening 139"" is formed. The first chamber 152"" is fluidly connected to a vent passage 156"" in the first housing portion 142 "". The second chamber 154"" is fluidly connected to the fluid passage 127a "" of the dry-break coupler 126 "". In this arrangement, as will be explained, the first channel 136"" forms part of a vent line 160"" which equalizes the pressure in the CSTD 100"" with the external atmospheric pressure, while the second channel 138"" forms part of a transfer line 170"" for transferring liquid between the first and second fluid reservoirs. The vent line 160"" and the transfer line 170"" are isolated from each other within the CSTD 100"" such that gas carried in the vent line 160"" does not enter the transfer line 170"", and liquid carried in the transfer line does not enter the vent line.

Each chamber in CSTD 100"" is configured to contain a filter material or filter component specific to each respective line. However, the chamber need not contain any filters. In this example, the first chamber 152"" contains a first filter component in the form of a hydrophobic filter 162"" and the second chamber 154"" contains a second filter component in the form of a particulate filter 164"" arranged in a coplanar arrangement parallel to the hydrophobic filter. The hydrophobic filter 152"" is optional and the particulate filter 164"" is optional, depending on the application.

Vent line 160"" allows air from the atmosphere to enter CSTD 100"". The hydrophobic filter 162"" is configured to allow air from the atmosphere to travel through the hydrophobic filter while not allowing liquid and aerosol in the air to travel through the hydrophobic filter. This prevents contaminants from the atmosphere from traveling through the first chamber 152"", through the first channel 136"", and into the second fluid reservoir. It also prevents or substantially prevents liquid and aerosol from the second fluid reservoir from exceeding the first chamber 152'. The hydrophobic filter 162"" may have any suitable pore size, including but not limited to a pore size of 0.2 microns.

The particulate filter 164"" is configured to allow liquid to pass through the particulate filter, but not small particulates to pass through the particulate filter. This prevents particles in the first fluid reservoir from being transported to the second fluid reservoir and vice versa. Particulate filters according to the present disclosure may be composed of any suitable material for filtering particles, including but not limited to membranes formed from acrylic copolymers, polyethersulfones, or polyvinylidene fluoride.

A vent line 160"" extends from the first passageway 136"" through the first chamber 152"" and into the first housing portion 142 "". The vent line 160"" exits the first housing portion 142"" through the side port 164"" and into the third housing portion 146"". The third housing portion 146"" has a hollow housing structure that is connected to one side of the first housing portion 142"" and passes over the side port 164"". Referring to fig. 54, the third housing portion 146"" is shown as transparent to illustrate the interior and airflow direction through the third housing portion.

The interior of the third housing portion 146"", provides a flow channel 163"", which forms a section of the vent line 160 "". The third housing portion 146"" also includes a filter housing 165"". The filter housing 165 houses a third filter component in the form of an activated carbon filter 166. Third housing portion 146"" further includes an outlet 168"" adjacent to activated carbon filter 166 "". The outlet 168"" is covered by a cap 169"" to retain and protect the carbon filter 166"" within the third housing portion 146"" therein. Cap 169"" has a small outlet orifice 169a "" connected to atmosphere. The flow channel 163"" extends from the side port 164"" through the carbon filter 166"", and exits the third housing portion 146"", through the outlet aperture 169a "".

In this arrangement, gas under positive pressure in the second fluid reservoir can be expelled from CSTD 100"" by flowing through flow channel 163"" and carbon filter 166"" and then exiting to the atmosphere through outlet orifice 169a "" to the atmosphere. The evacuation of gas is schematically illustrated in fig. 54 by dashed arrows starting from side port 164"" to the end of outlet aperture 169a "". During this venting process, the carbon filter 166"" filters the gases to capture toxic components and prevent them from escaping into the atmosphere. The carbon filter 166"" works in series with the hydrophobic filter 162"" to filter the gas exiting the second fluid reservoir before it is vented to the atmosphere.

The flow channels 163"" also provide ventilation paths for the ventilation lines 160"" allowing air from the atmosphere to enter through the outlet apertures 169a "" and travel through the carbon filter 166"" and into the side ports 164 "". This can help equalize the pressure in the CSTD to facilitate fluid delivery. In fig. 54, ventilation of air is schematically shown by solid arrows connecting outlet holes 169a "" to side ports 164 "".

Carbon filters according to the present disclosure may have a variety of geometries. In this example, carbon filter 166"" is a cylindrical filter media having an inner face 166a "", an outer face 166b "", and a circumferential side wall 166c "". As shown in fig. 44, the gas flows in a "lateral" direction through the carbon filter 166"". That is, the gas does not travel through either inner face 166a "" or outer face 166b "". Instead, the gas travels through the side wall 166c "". This may provide a longer flow path and ensure that the entire volume of the filter is used to filter harmful components, allowing more filtration and increasing the filtering capacity.

Fig. 45 shows an alternative arrangement in which an activated carbon filter 266"" filters gas flowing in the "axial" direction indicated by the double ended arrow. The filter housing 265"" contains an activated carbon filter 266"", which in this embodiment has a frustoconical shape with an axial length that is longer than the axial length of the activated carbon filter 166 "". The activated carbon filter 266"" has an inner face 266a "", an outer face 266b "", and a sidewall 266c "". A carrier element 267 "formed of a gas impermeable material such as silicone surrounds a portion of the inner face 266a" and the side walls 266c ". The carrier element 267"" has an opening 267a "" that exposes a portion of the inner face 266a "" to allow gas to enter and leave that portion of the inner face. The outer face 266b "" of the carbon filter 266"" is covered by a cap 269"" having small outlet holes 269a "". The carrier element 267"" has a sidewall 267b "" that extends a distance X corresponding to a portion of the axial length of the carbon filter 266 "". In this arrangement, the carrier element 267"" and cap 269"" allow gas to enter and leave portions of the inner face 266a "" and the outer face 266b "" and flow in an axial direction through the carbon filter. The carrier element 267"" is compressed into the space between the sidewall 266c "" of the carbon filter 266"" and the filter housing 265"" forming a fluid tight seal preventing gas flow through the carbon filter in a lateral direction within the footprint. The gas entering the carbon filter 266 "through the inner face 266a" is directed through the filter in the axial direction for at least length X.

CSTDs according to the present disclosure may optionally include one or more mechanisms for allowing air to enter the CSTDs in a regulated manner. For example, a CSTD according to the present disclosure may have a variety of check valve configurations. Fig. 46 shows a CSTD 300"", having a housing 340"", containing an activated carbon filter 366"", and having an outlet aperture 369a "", according to an alternative embodiment. Check valve 380"" is positioned adjacent to outlet aperture 369a "". Check valve 380"" has valve element 382"" and valve opening 384"". The valve element 382"" "is a disk-like or other plate-like element that is configured to allow air to flow through the valve opening 384" ", in only one direction. The valve element 382"" is operable in an open position allowing air to enter the valve opening 382"" and into the CSTD 300"", and a closed position preventing air from entering the valve opening and the CSTD. The biasing element 386"", which may be a compression spring, leaf spring or other spring element, secures the valve element 382"", in the closed position when the biasing element is in a relaxed or relatively relaxed state. Biasing element 386"", is configured to compress, bend, or otherwise deflect when the atmospheric pressure outside of valve opening 384"" exceeds the pressure inside of housing 340"" by a certain threshold. When the threshold is exceeded, the biasing element deflects to allow the valve element 382"" to move to the open position and allow air to pass through the valve opening 384"" and into the housing 340 "".

Returning to fig. 38, vial clamp 190"" has a proximal end 192"", which has a fastener mechanism 193"". Fastener mechanism 193"" is configured to connect vial clamp 190"" to a vial spike, such as vial spike 120"". A vial clip according to the present disclosure may have a variety of fastener mechanisms for detachably connecting the vial clip to a vial spike, including one or more snap-fit connectors. In this embodiment, the fastener mechanism 193"" consists of four flexible arms 196"" which are connected to one another. Each flexible arm 196"" may flex between a relaxed state and a flexed state. In the relaxed state, each flexible arm 196"" extends parallel to the longitudinal axis Y. In the deflected state, each flexible arm 196"" flexes radially outwardly and away from the longitudinal axis Y, wherein energy is stored in the arm. Each flexible arm 196"" has a barbed end 197"", with an inwardly sloped face 198"". For clarity, some of the barb ends 197"" are not marked and the inwardly sloped faces 198"".

The flexible arms 196"" are spaced apart such that when the vial spike is connected to the vial clamp 190"" the barbed end 197"" and the inwardly sloped face 198"" abut the second cap 145"" of the vial spike 120"". When the second cap 145"" contacts the inwardly sloped face 198"" the flexible arms 196"" flex radially outwardly under stored energy to allow the second cap to travel between the barbed ends 197 "". Once the second cap 145"" and the first cap 143"" are clear of the barbed end 197"", the energy stored in the flexible arms 196"", is released and the flexible arms snap back to their relaxed state. At this point, as shown in fig. 47, barbed end 197"" is located above and bears against first cap 143"" to secure vial clamp 190"" to vial spike 120"".

Vial clamp 190"" includes a downwardly steeped arcuate flange 193"", which forms a generally cylindrical socket 199"". In the assembled state, socket 199"" receives spike connector 130"", with flange 193"" surrounding the spike connector. In this arrangement, flange 193"" forms a guard 195"" that protects the user from accidental sticking by prongs 134"" and the like. Socket 199"" is also configured to receive and surround a portion of a second fluid reservoir (e.g., the neck of a vial) to connect vial spike 120"" to the second fluid reservoir.

Referring to fig. 47-50, a CSTD 1000 is shown according to another embodiment. CSTD 1000 includes an assembly called a "vial spike" 1200 that is connected to a base or "vial clamp" 1900.CSTD 1000 has a longitudinal axis Y that runs through the central portions of vial spike 1200 and vial clamp 1900. The vial spike 1200 has a proximal end 1220 forming a first connector 1230 configured to be fluidly connected to a first fluid reservoir, such as a syringe. The vial spike 1200 also has a distal end 1240 forming a second connector 1250 configured to be fluidly connected to a second fluid reservoir, such as a vial. Once the vial spike 1200 is connected in fluid communication with the first fluid reservoir and the second fluid reservoir, respectively, the vial spike forms a closed fluid path between the first fluid reservoir and the second fluid reservoir. Such a closed fluid channel, also referred to herein as a "transfer line", allows liquid to be transferred between the first fluid reservoir and the second fluid reservoir in a sealed manner, thereby preventing release of the harmful drug into the environment.

The first connector 1230 is a dry-break coupler 1260. The dry-break coupler 1260 has a rectangular body 1270 defining a fluid passage 1270 a. The diaphragm 1280 is mounted in a fluid passageway 1270a within the rectangular body 1270. The rectangular body 1270 is configured to mate with and fluidly connect to a syringe or other fluid reservoir.

The second connector 1250 is a lancet connector 1300 having a cylindrical contour 1320 and a tip 1340. As will be explained, the spike connector 1300 has separate fluid passages that carry liquid and gas through the CSTD.

The vial spike 1200 has a three-part housing 1400 that forms a passageway for the flow of liquids and gases within the CSTD 1000. The housing 1400 includes a first housing portion 1420 adjacent to and fluidly connected with the dry-break coupler 1260. Housing 1400 also includes a second housing portion 1440 that is adjacent to and fluidly connected to spike connector 1300. In addition, the housing 1400 includes a third housing portion 1460 that is attached to one side of the first housing portion 1420.

The first housing portion 1420 has a first cover 1430 opposite the dry-break coupler 1260. The second housing portion 1440 has a second cover 1450 opposite the lancet connector 1300. The second cover 1450 is configured to connect with the first cover 1430 to join the first housing portion 1420 and the second housing portion 1440 together. The first cover 1430 and the second cover 1450 are shaped so as to form a narrow gap, void or space 1410 between the first housing portion 1420 and the second housing portion 1440. An annular lip portion 1470 extends around the perimeter of the first cover 1430 and protrudes from the first housing portion 1420. An annular wall portion 1480 extends around the perimeter of the second cap 1450 forming a receptacle slightly larger in size than the annular lip portion 1470. The annular wall portion 1480 is adapted to receive the annular lip portion 1470 to join the first housing portion 1420 to the second housing portion 1440 in a mating and sealing arrangement.

The first cover 1430 forms a divider wall 1490 that spans the center of the annular lip portion 1470 as shown in fig. 50. When the first cover 1430 is mated with the second cover 1450, the annular wall portion 1470 and the divider wall 1490 form two separate chambers within the first and second covers. The first chamber 1520 is formed on a first side of the divider wall 1490 and the second chamber 1540 is formed on a second side of the divider wall opposite the first side.

The first cover 1430 and the second cover 1450 are connected to each other such that they completely enclose the first and second chambers 1520, 1540 and seal the chambers in a fluid tight manner from the exterior of the vial spike 1200. In addition, the first cover 1430 and the second cover 1450 are connected to each other, isolating the first chamber 1520 from the second chamber 1540 in a fluid tight manner, and vice versa. In this regard, the first cover 1430 can be coupled to the second cover 1450 using any suitable method that isolates the chambers from the exterior of the vial spike 1200 and from each other. Suitable methods for establishing such a sealing arrangement include welding techniques such as ultrasonic welding, hot plate welding and laser welding. Suitable methods for establishing the sealing arrangement also include overmolding and gluing.

The spike connector 1300 has a first channel 1360 and a second channel 1380 extending parallel to the first channel. When the vial spike 1200 is fully assembled, the first channel 1360 is fluidly connected with the first chamber 1520 but not with the second chamber 1540. Further, the second channel 1380 is fluidly connected to the second chamber 1540, but not to the first chamber 1520. The first channel 1360 extends the entire length of the lancet connector 1300 and exits the prong 1340 in which the first opening 1370 is formed. The second fluid passage 1380 also extends the entire length of the spike connector 1300 and exits the spike 1340 in which the second opening 1390 is formed. The first chamber 1520 is fluidly connected to a vent passage 1560 in the first housing portion 1420. The second chamber 1540 is connected to a fluid conduit 1580 which in turn is fluidly connected to a fluid passage 1270a of the dry-break coupler 1260. In this arrangement, as will be explained, the first channel 1360 forms part of a vent line 1600 that equalizes pressure in the CSTD 1000, while the second channel 1380 forms part of a transfer line 1700 for transferring liquid between the first fluid reservoir and the second fluid reservoir. Vent line 1600 and transfer line 1700 are isolated from each other within CSTD 1000 such that gas carried in vent line 1600 does not enter transfer line 1700 and liquid carried in the transfer line does not enter the vent line.

Each chamber in CSTD 1000 is configured to contain a filter material or filter component specific to each respective line. However, the chamber need not contain any filters. In this example, the first chamber 1520 contains a first filter component in the form of a hydrophobic filter 1620 and the second chamber 1540 contains a second filter component in the form of a particulate filter 1640, the particulate filters being arranged in a coplanar arrangement parallel to the hydrophobic filter.

CSTD 1000 has a "pressure equalization" mechanism 1800 designed to equalize pressure when a pressure gradient occurs between appliances or between the inside and outside of the device. When CSTD 1000 is attached to a vial and syringe and liquid is transferred between the vial and syringe by the device, such as during withdrawal of liquid from the vial or injection of liquid into the vial, a pressure gradient may occur.

The pressure balancing mechanism 1800 includes a check valve 1820 connected to one side of the first housing portion 1420 and an inflatable barrier or membrane 1840 connected to the third housing portion 1460. The membrane 1840 is configured to expand in response to the flow of gas into the third housing portion 1460 and to collapse in response to the discharge of gas from the third housing portion. When gas is released from the vial after penetration with spike connector 1300, the gas will travel through the spike connector, second housing portion 1440, first housing portion 1420 and into third housing portion 1460. Once inside the third housing portion 1460, the gas is captured and collected by the membrane 1840. The membrane 1840 is configured to expand to equalize the pressure in the CSTD 1000 when the third housing portion 1460 receives gas. The gas may remain stored in third housing portion 1460 and membrane 1840 until a pressure drop occurs in CSTD 1000. When a sudden pressure drop occurs in CSTD 1000, the gas stored in third housing portion 1460 and membrane 1840 is released into first housing portion 1420 to equalize the pressure. As will be described, if additional gas is required to balance the pressure, the check valve 1820 is configured to allow air external to the CSTD 1000 to flow into the first housing portion 1420 to balance the pressure.

Vent line 1600 allows gas from third housing portion 1460 and membrane 1840 to flow into other portions of CSTD 1000 to equalize pressure. In addition, vent line 1600 allows air entering CSTD 1000 through check valve 1820 to flow into different portions of CSTD 1000 to equalize pressure. The hydrophobic filter 1620 is configured to allow gas to flow through the hydrophobic filter to and from the spike connector 1300 while not allowing liquid and aerosol in the gas to travel through the hydrophobic filter. This prevents contaminants from the atmosphere from traveling through the first chamber 1520, through the first channel 1360, and into the second fluid reservoir. It also prevents or substantially prevents liquid and aerosols from the second fluid reservoir from exceeding the first chamber 1520. The hydrophobic filter 1620 may have any suitable pore size, including but not limited to a pore size of 0.2 microns.

The particulate filter 1640 is configured to allow liquid to travel through the particulate filter but not small particles to travel through the particulate filter. This prevents particles from the first fluid reservoir from being transported to the second fluid reservoir and vice versa. Particulate filters according to the present disclosure may be formed from any suitable material for filtering particles, including but not limited to films formed from acrylic copolymers, polyethersulfones, or polyvinylidene fluoride.

Referring to fig. 50 and 51, a vent line 1600 extends from the first channel 1360, through the first chamber 1520, and into the vent channel 1560 of the first housing portion 1420. The interior of the first housing portion 1420 provides an elongated flow channel 1630 that forms a section of the vent line 1600. The first housing portion 1420 defines a check valve housing 1650 on one side of the flow channel 1630. The check valve housing 1650 includes a check valve 1670. First housing portion 1420 further includes an outlet 1680 adjacent to check valve 1670. Inlet 1680 is covered by cap 1690 to secure check valve 1670 within check valve housing 1650. Cap 1690 has small hole 1690a connected to the atmosphere.

CSTDs according to the present disclosure can have a variety of check valve configurations. In this example, the check valve 1670 includes a resiliently flexible valve element 1670a within the check valve housing 1650. The valve element 382 is a cup-shaped element configured to allow air to flow through the check valve housing 1650 in only one direction. In particular, valve element 1670a is movable between an open position that allows air to enter inlet 1680 and into first housing portion 1420, and a closed position that prevents air from exiting the first housing portion through the inlet. When the valve element is in a relaxed or relatively relaxed state, the valve element 1670a adopts a closed position. In the closed position, valve element 1670a presses against inlet 1680 to prevent gas from entering or exiting first housing portion 1420. When the atmospheric pressure outside of inlet 1680 exceeds the pressure inside first housing portion 1420 by a certain threshold, valve element 1670a moves inwardly and away from inlet 1680. This allows air to enter inlet 1680 and flow into first housing portion 1420 to equalize the pressure in CSTD 1000.

The first housing portion 1420 has a first end 1550 configured to connect with a second end 1720 on a third housing portion 1460. The first end 1550 has an end opening 1570 at one end of the first channel 1630. When the third housing portion 1460 is connected to the first housing portion 1420, the end opening 1570 is positioned in alignment with the opening 1740 at the second end 1720. In this arrangement, the end opening 1570 and the opening 1740 form a fluid passageway interconnecting the first housing portion 1420 and the third housing portion 1460 in fluid communication. Second end 1720 may be connected to first end 1550 in a variety of suitable ways, including welding techniques such as ultrasonic welding, hot plate welding, and laser welding. Other suitable methods include overmolding and gluing.

The check valve housing 1650 is fluidly connected to the first channel 1630 at connection 1710. The first channel 1630 extends through the first housing portion 1420 and splits or branches in two different directions at the junction 1710. That is, the first channel 1630 splits into a first branch 1630a that faces the check valve 1670 and a second branch 1630b that faces the slot 1550.

Gas under positive pressure in second fluid reservoir 1640 is discharged from CSTD 1000 by flowing up vent line 1600 and into flow channel 1630. Once the gas reaches the junction 1710, the gas is prevented from exiting the CSTD 1000 through the first branch 1630a because the valve element 1670a of the check valve 1670 is moved to a closed position, blocking the inlet 1680. Thus, as previously described, the gas at the junction 1710 continues through the second branch 1630b and the end opening 1570 until it enters the third housing portion 1460. The membrane 1840 is configured to expand in response to the ingress of gas into the third housing portion 1460. The volume or size of the membrane 1840 changes in response to the gas entering the membrane. The increased size of membrane 1840 is visibly detected from outside of CSTD 1000, informing the user that gas is being stored in third housing portion 1460, rather than exiting the CSTD. The discharge of gas from the second fluid reservoir 1640 into the membrane 1840 is schematically illustrated in fig. 51 by dashed arrows.

The gas stored in the membrane 1840 under pressure may equilibrate in pressure as the negative pressure gradient develops. The gas exits the third housing portion 1460 through the opening 1740 and enters the flow channel 1630 in the first housing portion 1620. From there, the gas may travel along vent line 1700 and into second housing portion 1440 to equalize the pressure. If a sufficient amount of gas is not stored in membrane 1840 to balance the pressure in CSTD 1000 and a pressure gradient still exists, then higher pressure air from the external atmosphere will open valve element 1670a and enter first housing portion 1620 through inlet 1680. Air will enter inlet 1680 and fill CSTD 1000 until a pressure balance is achieved between the inside of the CSTD and the outside air. This can help equalize the pressure in the CSTD to facilitate fluid delivery. Ventilation of air through inlet 1680 is schematically illustrated in fig. 51 with solid arrows.

Returning to fig. 48 and 49, the vial clamp 1900 has a proximal end 1920 with a fastener mechanism 1930. The fastener mechanism 1930 is configured to connect the vial clamp 1900 to a vial spike, such as the vial spike 1200. A vial clip according to the present disclosure may have a variety of fastener mechanisms for detachably connecting the vial clip to a vial spike, including one or more snap-fit connectors. In this embodiment, the fastener mechanism 1930 is in the form of a flexible arm 1960. Each flexible arm 1960 is bendable between a relaxed state and a flexed state. In the relaxed state, each flexible arm 1960 extends parallel or substantially parallel to the longitudinal axis Y. In the deflected state, each flexible arm 1960 flexes radially outwardly and away from the longitudinal axis Y, wherein energy is stored in the arm. Each flexible arm 1960 has a barb end 1970 with an inwardly sloped face 1980.

The flexible arms 1960 are configured such that when the vial spike is connected to the vial clamp 1900, the barbed end 1970 and the inwardly sloped face 1980 abut the second cap 1450 of the vial spike 1200. When the second cap 1450 contacts the inwardly sloped surface 1980, the flexible arms 1960 flex radially outwardly under the stored energy to allow the second cap to travel between the barb ends 1970. Once the second and first covers 1450, 1430 are clear of the barbed ends 1970, the energy stored in the flexible arms 1960 is released and the flexible arms snap back to their relaxed state, functioning as a catch. At this point, the barbed ends 1970 engage tabs on the opposite side of the first housing portion 1420 to connect the vial clamp 1900 to the vial spike 1200.

The vial clamp 1900 includes a downwardly steeped arcuate flange 1910 that forms a generally cylindrical receptacle 1990. In an assembled state, the receptacle 1990 receives the spike connector 1300 with the flange 1910 surrounding the spike connector. In this arrangement, the flange 1910 forms a guard 1950 that protects the user from accidental sticking by the prongs 1340. The receptacle 1990 is also configured to receive and surround a portion of a second fluid reservoir (e.g., the neck of a vial) to connect the vial spike 1200 to the second fluid reservoir.

Some CSTDs according to the present disclosure have components specifically designed for filters, or have components specifically designed for inflatable barriers. Examples of these CSTDs are shown in fig. 37 to 51. Other CSTDs according to the present disclosure have common components that can be assembled to a filter or inflatable barrier. The latter type of CSTD may be provided in a modular system that allows for the selection and combination of different sets of components.

Referring to fig. 52, an example of a modular system 2100 "with a vial adapter is shown. Modular system 2100 "includes a set of components from which individual parts can be selected to assemble a CSTD having a desired application or function. The components may be selected and assembled to produce a CSTD that works with a particular type or size of fluid container or reservoir. In addition, the components may be selected and assembled to produce a CSTD that equalizes the pressure gradient in some manner. For example, a subset of components (referred to herein as a "module") may be selected to filter the harmful gases and vent the filtered gases to the atmosphere. Another subset of components or modules may be selected to capture the harmful gases and store the gases within the CSTD. Different CSTDs can be customized and manufactured from a common set of components, thereby improving manufacturing efficiency.

The modular system 2100 "includes a core or" base assembly "2105" and four separate modules 2110A ", 2110B", 2112A "and 2112B". The base assembly 2105 "forms a central structure about which the different CSTDs can be assembled. The modules 2110A "and 2110B" are interchangeable clamp modules 2110 "that allow the base assembly 2105" to be connected to containers of different sizes depending on the clamp module selected. Modules 2112A "and 2112B" are interchangeable ventilation modules 2112 "that allow the pressure in the CSTD to equalize in some manner depending on the ventilation module selected. The base assembly 2105 "is configured to be connected to one clamp module 2110" at a time and to one vent module 2112 "at a time to form a CSTD. Thus, the assembled CSTD in this example may include a base assembly 2105 "connected to one of the clamp modules 2110" and one of the vent modules 2112 ".

The base assembly 2105 "is a part subassembly that can be assembled prior to adding the clamp module 2110" and the vent module 2112 ". The part subassembly includes a vial spike 2120 "and a gas exchange unit 2180". The vial spike 2120 "may be connected to module 2110A" or module 2110B "and the gas exchange unit 2180" may be connected to module 2112A "or module 2112B". The vial spike 2120 "and the gas exchange unit 2180" are manufactured separately by injection molding and then joined together using ultrasonic welding or other joining techniques.

The base assembly 2105 "manages the flow of liquid and gas through the CSTD after the CSTD is connected to the first and second fluid reservoirs. The vial spike 2120 "forms a transfer channel that allows liquid in the first fluid reservoir to travel in a sealed environment to the second fluid reservoir. The gas exchange unit 2180 "forms part of a vent channel that equalizes the pressure within the CSTD after the vial spike 2120" is connected to the first fluid reservoir and the second fluid reservoir. As will be explained, the transport channel and the ventilation channel are physically separated from each other.

Referring to fig. 53 and 54, a vial spike 2120 "has a proximal end 2122" forming a first connector 2123 "configured to be fluidly connected to a first fluid reservoir, such as a syringe. The vial spike 2120 "also has a distal end 2124" forming a second connector 2125 "configured to be fluidly connected to a second fluid reservoir, such as a vial. Once the vial spike 2120 "is connected in fluid communication with the first fluid reservoir and the second fluid reservoir, respectively, the vial spike forms a closed fluid channel between the first fluid reservoir and the second fluid reservoir. Such a closed fluid channel, also referred to herein as a "transfer line", allows liquid to be transferred between the first fluid reservoir and the second fluid reservoir in a sealed manner, thereby preventing release of the harmful drug into the environment.

A vial spike according to the present disclosure may have various fluid connectors at the proximal and distal ends. In this embodiment, the first connector 2123 "is a luer lock connector 2126". Luer lock connector 2126 "has a body 2127" defining a fluid passage 127A ". The diaphragm 2128 "is mounted in the fluid channel 127A" within the body 2127". The body 2127 "has external threads 2129" configured to mate with internal threads on a syringe or other fluid reservoir.

The second connector 2125 "is a spike connector 2130" having a cylindrical profile 2132 "and a spike 2134". As will be explained, the spike connector 2130 "has separate fluid passages that carry liquid and gas through the CSTD.

Vial spike 2120 "has a two-part housing 2140" that forms a passageway for the flow of liquid and gas within the CSTD. The housing 2140 "includes a first housing portion 2142" adjacent to and fluidly connected to the luer lock connector 2126". The housing 2140 "also includes a second housing portion 2144" that is adjacent to and fluidly connected to the spike connector 2130".

The first housing portion 2142 "has a first cover 2143" opposite the luer lock connector 2126". The second housing portion 2144 "has a second cover 2145" opposite the spike connector 2130". The second cover 2145 "is configured to connect with the first cover 2143" to join the first and second housing portions 2142", 2144" together. The first and second covers 2143", 2145" form an enlarged flange section that serves as a finger stop or finger rest providing greater comfort in securing the device.

The first and second covers 2143", 2145" also form a narrow gap, void, or space 2141 "between the first and second housing portions 2142", 2144". An annular lip portion 2147 "extends around the perimeter of the first cover 2143" and protrudes from the first housing portion 2142 ". The annular wall portion 2148 "extends around the perimeter of the second cover 2145" forming a receptacle slightly larger in size than the annular lip portion 2147 ". The annular wall portion 2148 "is adapted to receive the annular lip portion 2147" to join the first housing portion 2142 "to the second housing portion 2144" in a mating and sealing arrangement.

Referring to fig. 54-55, the first cover 2143 "has a divider wall 2149" that spans the center of the annular lip portion 2147 "as shown. When the first cap 2143 "is mated with the second cap 2145", the annular wall portion 2148 "and the divider wall 2149" form two separate chambers within the first cap and the second cap. The first chamber 2152 "is formed on a first side of the divider wall 2149" and the second chamber 2154 "is formed on a second side of the divider wall opposite the first side.

The first and second caps 2143", 2145" are connected to each other such that they completely enclose the first and second chambers 2152", 2154" and isolate the chambers from the exterior of the vial spike 2120 "in a fluid-tight manner. Furthermore, the first and second covers 2143", 2145" are connected to each other, isolating the first chamber 2152 "from the second chamber 2154" in a fluid tight manner, and vice versa. In this regard, the first cap 2143 "may be joined to the second cap 2145" using any suitable method that isolates the chambers from the exterior of the vial spike 2120 "and from each other. Suitable methods for establishing such a sealing arrangement include welding techniques such as ultrasonic welding, hot plate welding, and laser welding or other joining techniques. Suitable methods for establishing the sealing arrangement also include overmolding and gluing.

The spike connector 2130 "has a first passageway 2136" and a second passageway 2138 "extending parallel to the first passageway. When the vial spike 2120 "is fully assembled, the first channel 2136" is fluidly connected to the first chamber 2152 "but not to the second chamber 2154". Further, the second passage 2138 "is fluidly connected to the second chamber 2154" but not to the first chamber 2152". The first channel 2136 "extends the entire length of the spike connector 2130" and exits the spike 2134 "in which the first opening 2137" is formed. The second fluid passageway 2138 "also extends the entire length of the spike connector 2130" and exits the spike 2134 "in which the second opening 2139" is formed. The first chamber 2152 "is fluidly connected to a vent channel 2156" in the first housing portion 2142 ". The second chamber 2154 "is fluidly connected to the fluid channel 127A" of the luer lock connector 2126 ". In this arrangement, as will be explained, the first channel 2136 "forms part of a vent line 2160" that equalizes pressure in the modular system 2100 "with external atmospheric pressure, while the second channel 2138" forms part of a transfer line 2170 "for transferring liquid between the first and second fluid reservoirs. Vent line 2160 "and transfer line 2170" are isolated from each other within the CSTD such that gas carried in vent line 2160 "does not enter transfer line 2170" and liquid carried in the transfer line does not enter the vent line.

Each chamber in the modular system 2100 "is configured to contain a filter material or filter component specific to each respective line. In this example, the first chamber 2152 "contains a first filter component in the form of a hydrophobic filter 2162" and the second chamber 2154 "contains a second filter component in the form of a particulate filter 2164" arranged parallel to the hydrophobic filter in a coplanar arrangement. Particulate filter 2164″ is optional depending on the application.

The enlarged flange shape of the first and second covers 2143", 2145" provides an enlarged cross-sectional area within the cover. That is, the cross-sectional area of the first chamber 2152 "is much greater than the cross-sectional area of the first channel 2136" and the cross-sectional area of the second chamber 2154 "is much greater than the cross-sectional area of the second channel 2138". The large cross-sectional areas of the first and second chambers 2152", 2154" allow for larger filters to be used. This increases the surface area of the filter and increases the flow rate through the chamber.

As will be explained, vent line 2160 "allows air from the atmosphere to enter the CSTD. The hydrophobic filter 2162 "is configured to allow air from the atmosphere to travel through the hydrophobic filter while not allowing liquid and aerosols in the air to travel through the hydrophobic filter. This prevents contaminants from the atmosphere from traveling through the first chamber 2152", through the first channel 2136" and into the second fluid reservoir. It also prevents or substantially prevents liquid and aerosols from the second fluid reservoir from exceeding the first chamber 2152". Hydrophobic filter 2162 "may have any suitable pore size, including, but not limited to, a pore size of 0.2 microns.

Particulate filter 2164 "is configured to allow liquid to travel through the particulate filter, but not small particulates to travel through the particulate filter. This prevents particles in the first fluid reservoir from being transported to the second fluid reservoir and vice versa. Particulate filters according to the present disclosure may be composed of any suitable material for filtering particles, including but not limited to films formed from acrylic copolymers, polyethersulfones, or polyvinylidene fluoride.

A vent line 2160 "extends from the first passageway 2136", through the first chamber 2152 "and into the first housing portion 2142". The vent line 2160 "exits the first housing portion 2142" through the side port 163 "and enters the gas exchange unit 2180".

Referring to fig. 56 and 57, the gas exchange unit 2180 "has a hollow housing structure or body 2182" connected to one side of the first housing portion 2142 "and passing over the side port 163. The body 2182 "has a body width 2182W" and a body length 2182L "that is significantly greater than the body width, thereby forming a narrow profile. The interior of the body 2182 "provides a gas exchange passage 2181" forming a section of the vent line 2160 ". The gas exchange passage 2181 "enters the body 2182" through the first port 2182A "and is fluidly connected to a plug-in socket 2185" located in the central portion of the body. The gas exchange passages 2181 "exit the plug-in sockets 2185" and are fluidly connected to the elongated slots 2186". The slot 2186 "exits the body 2182" to the exterior of the body through a second port 2182B ".

The gas exchange unit 2180 "is configured to connect to and receive a ventilation module 2112A" or a ventilation module 2112B ". The ventilation module 2112A "converts the gas exchange unit 2180" into a filter unit that filters the harmful gases from the CSTD before venting the gases to the atmosphere. The ventilation module 2112B "converts the gas exchange unit 2180" into a gas storage unit that holds the harmful gases within the CSTD and prevents the release of the gases to the atmosphere. In this arrangement, the ventilation modules 2112A "and 2112B" provide interchangeable subassemblies that work in concert with the base assembly 2105 "to provide two different options for managing harmful gases and ventilation in the CSTD. As previously described, this allows for the manufacture and assembly of different CSTDs using one base assembly design, thereby improving manufacturing efficiency.

Returning to fig. 52, ventilation module 2112A "includes a carbon filter 2166" designed to filter harmful gases in ventilation line 2160 ". The plug-in receptacle 2185 "forms a filter housing 2165" adapted to receive the carbon filter 2166 ". The ventilation module 2112A "also includes a cap 169 that closes the plug-in socket 2185" in a gas-tight arrangement after the carbon filter 2166 "is received in the filter housing 2165" to secure and protect the carbon filter within the gas exchange unit 2180 ". During operation, the harmful gases in vent line 2160 "enter gas exchange passage 2181" and pass through carbon filter 2166", where they are filtered to remove toxins. The filtered gas then exits the filter housing 2165 "and travels through the elongated receptacle 2186" to the second port 2182B ", where it is released into the atmosphere.

When the ventilation module 2112A "is used with the gas exchange unit 2180", the gas exchange channels 2181 "provide a bi-directional ventilation path for the ventilation line 2160". That is, as described above, gas may flow in a first direction through gas exchange passage 2181 "where the gas is filtered by carbon filter 2166" and released into the atmosphere. In addition, gas exchange passage 2180 "allows air from the atmosphere to enter through second port 2182B" and flow through vent line 2160 "in a second direction opposite the first direction to equalize the pressure in the CSTD.

Carbon filters according to the present disclosure may have a variety of geometries. In this example, carbon filter 2166 "is a cylindrical filter media. The gas flows in a "lateral" direction through the side wall 167 of the carbon filter 2166 ". This provides a longer flow path and ensures that the entire volume of the filter is used to filter harmful components, allowing more filtration and increasing the filtration capacity.

The venting module 2112B "includes a check valve 2172" in combination with an inflatable barrier or reservoir 2174 ". The male receptacle 2185 "is configured to connect to and receive a check valve 2172". The check valve 2172 "is a one-way valve that allows air from the atmosphere to enter the gas exchange unit 2180", but prevents gas from exiting the gas exchange unit. The check valve 2172 "is thus configured to open to allow air from the atmosphere to enter the gas exchange unit 2180" and flow into the vent line 2160 "to equalize the pressure in the CSTD. The check valve 2172 "is also configured to close in response to positive pressure in the gas exchange passage 2182", such as to prevent the escape of harmful gases to the atmosphere through the check valve when the harmful gases are released from the reservoir into the gas exchange passage.

The reservoir 2174 "is configured to connect to the second port 2182B" to form an inflatable storage bladder attached to the gas exchange unit 2180 ". In this arrangement, reservoir 2174 "is configured to collect gas entering gas exchange unit 2180" from vent line 2160 ". The reservoir 2174 "is also configured to discharge stored gas into the gas exchange passage 2181" and vent line 2160 "to equalize the pressure as the pressure in the CSTD drops. When the reservoirs 2174 "collect gas, the membrane expands, providing a visual indicator or alarm that the harmful gas is being released from one of the reservoirs and stored within the CSTD. When reservoir 2174 "vents gas, the membrane collapses, creating a visual indicator or alarm that the pressure in the CSTD is being equalized.

When gas is released from the vial after penetration with spike connector 2130", the gas will travel through the vial spike 2120" and into gas exchange unit 2180 ". Once inside the gas exchange unit 2180", the gas flows through the plug-in socket 2185" and is captured and collected by the reservoir 2174 ". The captured gas may remain stored in reservoir 2174 "until a pressure drop occurs in the CSTD. When a pressure drop occurs in the CSTD, the gas stored in reservoir 2174 "is released into gas exchange passage 2181" and vent line 2160 "to equalize the pressure. If additional gas is required to balance the pressure, the check valve 2172 "is configured to allow air outside of the CSTD 2100" to flow into the first housing portion 2142 "to balance the pressure.

Fig. 58-61 illustrate four different CSTDs that can be assembled using the modular system 2100 ". In FIG. 58, CSTD 2101A "includes a base assembly 2105" attached to a clamp module 2110A "and a vent module 2112A". In FIG. 59, CSTD 2101B "includes a base assembly 2105" attached to a clamp module 2110B "and a vent module 2112A". In FIG. 60, CSTD 2101C "includes a base assembly 2105" attached to a clamp module 2110A "and a vent module 2112B". In FIG. 61, CSTD 2101D "includes a base assembly 2105" attached to a clamp module 2110B "and a vent module 2112B". Thus, the selection of each clamp module may be done independently of which ventilation module is used, and vice versa.

Clip module 2110A "is designed to attach to a 13-20mm vial. Clip module 2110B "is designed to be attached to a 32mm vial. It should be appreciated that a gripper module according to the present disclosure may be configured to connect to other gripper modules of any vial size or range of sizes, as well as other types of containers. Accordingly, clamp modules 2110A "and 2110B" should be understood to represent only two examples of modules that may be used with a base assembly in accordance with the present disclosure.

Fig. 62 shows a modular system 2200 according to an alternative embodiment. Like modular system 2100", modular system 2200" comprises a set of components from which individual parts can be selected to assemble a CSTD having a desired application or function. The components may be selected and assembled to produce a CSTD that works with a particular type or size of fluid vessel. In addition, the components may be selected and assembled to produce a CSTD that equalizes the pressure gradient in some manner. For example, a subset of the components may be selected to filter the harmful gases and vent the filtered gases to the atmosphere. Another subset of components may be selected to capture the harmful gases and store the gases within the CSTD. Different CSTDs can be customized and manufactured from a common set of components, thereby improving manufacturing efficiency.

Unlike modular system 2100", modular system 2200" has a core or base assembly 2205 "with a gas exchange unit 2280" integrated into vial spike 2220 ". This arrangement reduces the number of parts that must be manufactured to form base assembly 2205 "and it eliminates the step of attaching gas exchange unit 2280" to vial spike 2220 ".

Modular system 2200 "also includes four independent modules 2210A", 2210B ", 2212A" and 2212B ", which may be individually selected for connection to base component 2205", similar to modular system 2100". The base assembly 2205 "forms a central structure from which different CSTDs can be assembled via attachment to different modules. Modules 2210A "and 2210B" are interchangeable clip modules 2210 "that allow base assembly 2205" to be connected to containers of different sizes depending on the clip module selected. Modules 2212A "and 2212B" are interchangeable vent modules 2212 "that allow the pressure in the CSTD to equalize in some manner depending on the vent module selected.

The base assembly 2205 "is configured to connect with a clamp module 2210" and a vent module 2212 "to form a CSTD. Thus, the CSTD assembled in this example may include a base assembly 2205", one clamp module 2210", and one vent module 2212". The vial spike 2220 "may be connected to module 2210A" or module 2210B "and the gas exchange unit 280" may be connected to module 2212A "or module 212B. The base assembly 2205 "manages the flow of liquid and gas through the CSTD after the CSTD is connected to the first and second fluid reservoirs.

The base assembly according to this embodiment may be manufactured with the same or similar components and features as in modular system 2100 ". Thus, for the sake of brevity, some components and features in base assembly 2205 "will not be described, it being understood that these components and features may be the same components and features in base assembly 2105", or substantially similar to these components and features.

Vial spike 2220 "forms a transfer line 2270" that allows liquid in the first fluid reservoir to travel in a sealed environment to the second fluid reservoir. The gas exchange unit 2280 "forms part of a vent line 2260" that equalizes the pressure within the CSTD after the vial spike 2220 "is connected to the first fluid reservoir and the second fluid reservoir. The transfer line 2270 "and vent line 2260" are physically separated from each other.

The base assembly 2205 "also includes an outer housing 2206" that can be attached over the top of the vial spike 2220 "and the gas exchange unit 2280". The vial spike 2220 "has a dry-break coupler 2260" defining a fluid passageway 2227A ". The dry break coupler 2260 "prevents the release of liquid or vapor from the CSTD during coupling or decoupling of the vial spike to the first fluid reservoir. The dry break coupler 2260 "has a cylindrical body 2227" defining a fluid passageway 2227A ". Fluid passage 2227A "forms part of delivery line 2270". The septum 2228 "is mounted in the fluid channel 2227A". The diaphragm 2228 "cooperates with a suitable coupler on the first fluid reservoir to form a sealed connection.

The gas exchange unit 2280 "has a cylindrical body 2282" with a first open end 2282A "and a second open end 2282B". Referring to fig. 64 and 66, the interior of the body 2282 "forms part of a transfer line 2270". The interior of the body 2282 "also forms a gas exchange passage 2283" that is isolated from and fluidly isolated from the delivery line 2270 ". The gas exchange passages 2283 "forming a section of vent line 2260" enter the body 2282 "through the first port 2281".

Returning to fig. 62, the first and second open ends 2282A ", 2282B" are configured to connect with the ventilation module 2212A ", or alternatively, with the ventilation module 2212B". The flow of air through the air exchange passage 2283 "is changed and depends on which ventilation module 2212" is connected to the air exchange unit 2280". The ventilation module 2212A "converts the gas exchange unit 2280" into a filter unit that filters the harmful gases from the CSTD before venting the gases to the atmosphere. The ventilation module 2212B "converts the gas exchange unit 2280" into a gas storage unit that holds the harmful gases within the CSTD and prevents the release of the gases to the atmosphere. In this arrangement, the ventilation modules 2212A "and 2212B" provide interchangeable subassemblies that work in conjunction with the base assembly 2205 "to provide two different options for managing harmful gases and ventilation in the CSTD.

Fig. 63 shows components of the ventilation module 2212A "and fig. 64 shows the inside of the gas exchange unit 2280 to which the ventilation module 2212A" is mounted. The ventilation module 2212A "includes a hydrophobic air filter 2262" positioned over a first port 2281 "within the gas exchange unit 2280". The gas entering the gas exchange passage 2283 "from the first reservoir is immediately filtered by the hydrophobic air filter 2262". The airflow through hydrophobic air filter 2262 "is shown by arrow A1. The ventilation module 2212A "also includes a cover 2263" that closes the first open end 2282A "in a gas-tight arrangement to prevent gas from exiting the first open end. The gas entering gas exchange unit 2280 "travels through air filter 2262" and flows within gas exchange passage 2283 "toward second open end 2282B" as indicated by arrow A2.

The second open end 2282B "forms a filter housing 2265" that receives and filters toxins from gases traveling through the air filter 2262 ". The ventilation module 2212A "includes a filter housing 2269A", a filter cap 2269B ", and an activated carbon filter 2266". Filter housing 2269A "may be inserted into filter housing 2265" in second open end 2282B ". The carbon filter 2266 "is a disc-shaped filter media that may be inserted into the filter housing 2269A" after insertion into the second open end 2282B ". After the carbon filter 2266 "is received into the filter housing, the filter cap 2269B" may be glued, snapped onto, or otherwise attached to the filter housing 2269A "to secure and protect the carbon filter within the gas exchange unit 2280".

The filter housing 2269A "and filter cap 2269B" form a first opening 2269C "positioned toward the interior of the gas exchange unit 2280" and a second opening 2269D "adjacent the exterior of the gas exchange unit. During operation, as indicated by arrow A3, gas received from air filter 2262 enters filter housing 2269A "through first opening 2269C". From there, the gas flows laterally through an activated carbon filter 2266 "where it is filtered to remove toxins. The filtered gas then exits carbon filter 2266 "and exits filter housing 2269A" through a second opening 2269D "in which the gas is released to the atmosphere, as indicated by arrow A4.

When the vent module 2212A "is used with the gas exchange unit 2280", the gas exchange passage 2283 "provides a bi-directional vent path for the vent line 2260". That is, as described above, the gas exchange passages 2283 "allow the gas to be filtered through the carbon filter 2266" and released to the atmosphere. Furthermore, as indicated by arrow A5, gas exchange passage 2280 "allows air to enter from the atmosphere through second opening 2269D" and into first port 2281 "and then air to vent line 2260" to equalize the pressure in the CSTD so that fluid may be delivered between two reservoirs connected to the CSTD.

Fig. 65 shows components of the ventilation module 2212B ", and fig. 66 shows the inside of the gas exchange unit 2280″ to which the ventilation module 2212B" is mounted. The ventilation module 2212B "includes a one-way check valve 2272", a hydrophobic air filter 2273", an inflatable reservoir, barrier or reservoir 2274", and an adapter 2275". The adapter 2275 "is configured to be inserted into the second open end 2282B". When the adapter 2275 "is connected to the gas exchange unit 2280", the tubular stem 2275A "protrudes outwardly from the second open end 2282B". In this arrangement, a reservoir 2274 "may be attached to the valve stem 2275A" to connect the membrane to the gas exchange unit 2280".

As shown, the first open end 2282A "is configured to receive a hydrophobic air filter 2273" and a check valve 2272". A hydrophobic air filter 2273 "is connected over the first port 2281" (as shown in fig. 64), similar to hydrophobic air filter 2262". In this regard, hydrophobic air filter 2273 "may be identical to hydrophobic air filter 2262". The harmful gases entering the gas exchange passage 2283 "from the first reservoir are immediately filtered by the hydrophobic air filter 2273". The airflow through hydrophobic air filter 2262 "is shown by arrow B1. The check valve 2272 "is a one-way valve that allows air from the atmosphere to enter the gas exchange unit 2280" but prevents the gas from exiting the gas exchange unit. Accordingly, the harmful gas entering the gas exchange passage 2283″ from the first port is prevented from exiting the first open end 2282A″ but is directed to the second open end 2282B″ as indicated by arrow B2. From there, the harmful gases travel through the tubular stem 2275A ", as indicated by arrow B3, and enter the barrier 2274" where the gases are trapped in a sealed environment.

Check valve 2272 "is configured to open to allow air from the atmosphere to enter gas exchange unit 2280" and flow into vent line 2260 "to equalize the pressure in the CSTD. The check valve 2272 "is also configured to close in response to positive pressure in the gas exchange passage 2283", such as when a harmful gas enters the gas exchange passage from the first port 2281 ". This prevents harmful gases from escaping through the check valve to the atmosphere.

The reservoir 2274 "is configured to be connected to the second open end 2282B" to form an inflatable storage balloon similar to reservoir 2174 ". In this arrangement, the reservoir 2274 "is configured to collect gas that enters the gas exchange unit 2280" from the vent line 2260 ". The reservoir 2274 "is also configured to discharge the stored gas into the gas exchange passage 2283" and vent line 2260 "to equalize the pressure as the pressure in the CSTD decreases. When the reservoirs 2274 "collect gas, the membrane expands, providing a visual indicator or alarm that the harmful gas is being released from one of the reservoirs and stored within the CSTD. When the reservoir 2274 "vents gas, the membrane collapses, producing a visual indicator or alarm that the pressure in the CSTD is being equalized. Thus, when gas is released from the vial after penetration with spike connector 2230", for example, gas will pass through vial spike 2220" and into gas exchange unit 2280 ". Once inside the gas exchange unit 2280", the gas flows through the tubular stem 2275A" and is captured and collected by the reservoir 2274 ". The trapped gas may remain stored in reservoir 2274 "until a pressure drop occurs in the CSTD. When a pressure drop occurs in the CSTD, the gas stored in the reservoir 2274 "is released into the gas exchange passage 2283" and vent line 2260 "to equalize the pressure. If additional gas is required to balance the pressure, check valve 2272 "is configured to allow air outside the CSTD to flow into gas exchange unit 2280" and vent line 2260 "to balance the pressure.

Clamp modules 2210A "and 2210B" are equivalent to clamp modules 2110A "and 2110B". Thus, module 2210A "is designed to be connected to a 13-20mm vial, and fixture module 2210B" is designed to be connected to a 32mm vial. The selection of each clamp module may be done independently of which ventilation module is used, and vice versa.

Referring to fig. 67-84, another example of a modular CSTD 2100 with vial adapter is shown. The modular CSTD 2100 is similar to the CSTD that can be assembled in the modular system 2100 shown in fig. 52-61. Many features of the modular CSTD 2100 are the same or substantially similar to those of the modular system 2100 "and will not be described for the sake of brevity.

Modular CSTD 2100 includes a core or "base component" 2105 as shown in fig. 70. The base assembly 2105 may be connected to two interchangeable clip modules and two interchangeable vent modules. Unlike modular CSTD 2100", base assembly 2105 in modular CSTD 2100 comprises three components: vial spike 2120, gas exchange unit 2180 and modular adapter 2800.

Modular adapter 2800 includes an outer housing 2810 having a first end 2812 and a second end 2814. The first end 2812 is attached to the vial clamp 2900 and the second end 2814 is adapted to receive a syringe adapter. Modular adapter 2800 also includes an adapter member 2820 having a first end 2822 and a second end 2824. First end 2822 has a slot 2823 configured to receive coupler 2260 on vial spike 2120. A diaphragm 2830 is disposed in the second end 2824 of the adapter member 2820. Second end 2824 and septum 2830 are configured to form a dry break coupling between vial spike 2120 and the syringe adapter when the syringe adapter is inserted into second end 2814 of outer housing 2810.

The second end 2814 of the outer housing 2810 is configured to center the syringe adapter relative to the modular adapter 2800 as the syringe adapter enters the second end. The internal geometry of the outer housing 2810 keeps the septum of the syringe adapter aligned with the septum 2830 in the adapter member 2820. Thus, the outer housing 2810 acts as a centering mechanism or guide to control the position of the syringe adapter during insertion.

Modular adapter 2800 is configured to work with a ventilation module having an active filter housing or inflatable membrane. Referring to fig. 70, the outer housing 2810 has an opening 2816 that accommodates each type of ventilation module. When CSTD 2100 is equipped with an active filter housing, opening 2816 serves as both an exhaust port allowing filtered gas to exit the CSTD and a vent port allowing air from the atmosphere to enter the CSTD to equalize pressure. When CSTD 2100 is equipped with an inflatable membrane, opening 2816 provides a passageway that allows the inflatable membrane to be inserted into gas exchange unit 2180 within outer housing 2810.

Modular adapter 2800 can work with other vial adapter components such as the vial spike shown in fig. 37 and 47. In this case, the septum used to form the dry break coupler is located in the adapter member 2820, rather than in the vial spike.

The base assembly 2105 forms a central structure about which the different CSTDs can be assembled. The base assembly 2105 is configured to be connected to one clamp module at a time and to one vent module at a time to form a CSTD. Thus, the assembled CSTD may include a base assembly 2105 connected to a clamp module and a vent module.

The base assembly 2105 manages the flow of liquid and gas through the CSTD after the CSTD is connected to the first and second fluid reservoirs. The vial spike 2120 forms a transfer channel that allows liquid in the first fluid reservoir to travel in a sealed environment to the second fluid reservoir. The gas exchange unit 2180 forms part of a vent channel that equalizes the pressure within the CSTD after the vial spike 2120 is connected to the first fluid reservoir and the second fluid reservoir. The transfer passage and the ventilation passage are physically separated from each other.

Referring to fig. 68 and 69, the adapter member 2820 forms a first connector 2123 configured to fluidly connect to a syringe. The distal end of the vial spike 1200 forms a second connector 2125 configured to be fluidly connected to a second fluid reservoir, such as a vial. Once the vial spike 2120 is connected in fluid communication with the first fluid reservoir and the second fluid reservoir, respectively, the vial spike forms a closed fluid channel or transfer line between the first fluid reservoir and the second fluid reservoir. The transfer line allows liquid to be transferred between the first fluid reservoir and the second fluid reservoir in a sealed manner, thereby preventing release of the harmful drug into the environment.

The second connector 2125 is a spike connector 2130 having a cylindrical profile 2132 and a spike 2134. The spike connector 2130 has separate fluid passages that carry liquid and gas through the CSTD. Vial spike 2120 has a three-part housing 2140 that forms a passageway for the flow of liquid and gas within the CSTD. The housing 2140 includes a first housing portion 2142 adjacent to and fluidly connected with the adapter member 2820. The housing 2140 also includes a second housing portion 2144 that is adjacent to and fluidly connected to the spike connector 2130.

The first housing portion 2142 has a first cover 2143 and the second housing portion 2144 has a second cover 2145. The second cover 2145 is configured to be connected to the first cover 2143 to join the first and second housing portions 2142, 2144 together. The first and second covers 2143, 2145 form an enlarged flange section that serves as a finger stop or finger rest providing greater comfort in securing the device.

The first and second covers 2143, 2145 also form a narrow gap, void, or space 2141 between the first and second housing portions 2142, 2144. An annular lip portion 2147 extends around the periphery of the first cover 2143 and protrudes from the first housing portion 2142. The annular wall portion 2148 extends around the perimeter of the second cover 2145, forming a receptacle slightly larger in size than the annular lip portion 2147. The annular wall portion 2148 is adapted to receive the annular lip portion 2147 to join the first housing portion 2142 to the second housing portion 2144 in a mating and sealing arrangement.

The first and second covers 2143, 2145 form a first chamber 2152 and a second chamber 2154 that are separated by a divider wall 2149 when the first and second covers are mated together. The first and second caps 2143, 2145 are connected to each other such that they completely enclose the chamber and are isolated from the exterior of the vial spike 2120 in a fluid-tight manner. In addition, the first and second covers 2143 and 2145 are connected to each other to isolate the two chambers from each other.

Referring to FIG. 72, the spike connector 2130 has a first passageway 2136 and a second passageway 2138 extending parallel to the first passageway. When the vial spike 2120 is fully assembled, the first channel 2136 is fluidly connected to the first chamber 2152 but not to the second chamber 2154. Further, the second passage 2138 is fluidly connected to the second chamber 2154, but not to the first chamber 2152. The first channel 2136 extends the entire length of the spike connector 2130 and exits the spike 2134 in which the first opening 2137 is formed. The second fluid passageway 2138 also extends the entire length of the spike connector 2130 and exits the spike 2134 in which the second opening 2139 is formed. The first chamber 2152 is fluidly connected to a vent channel 2156 in the first housing portion 2142. The first chamber 2154 is fluidly connected to a fluid passage 2127 in the coupler 2260. In this arrangement, first passageway 2136 forms part of vent line 2160 that equalizes pressure in modular CSTD 2100 with external atmospheric pressure, while second passageway 2138 forms part of transfer line 2170 for transferring liquid between the first and second fluid reservoirs. Vent line 2160 and transfer line 2170 are isolated from each other within the CSTD such that gas carried in vent line 2160 does not enter transfer line 2170 and liquid carried in the transfer line does not enter the vent line.

Each chamber in modular CSTD 2100 is configured to contain a filter material or filter component specific to each respective line. Fig. 70, 74, 79 and 84 each only show a hydrophobic filter element 2162 for placement in the vent line 2160. It should be appreciated that the modular CSTD 2100 may also include a particulate filter in the transfer line 2170.

Vent line 2160 allows air from the atmosphere to enter the CSTD. The hydrophobic filter 2162 is configured to allow air from the atmosphere to travel through the hydrophobic filter while not allowing liquid and aerosols in the air to travel through the hydrophobic filter. This prevents contaminants from the atmosphere from traveling through the first chamber 2152, through the first channel 2136 and into the second fluid reservoir. It also prevents or substantially prevents liquid and aerosols from the second fluid reservoir from exceeding the first chamber 2152. Hydrophobic filter 2162 may have any suitable pore size, including, but not limited to, a pore size of 0.2 microns.

A vent line 2160 extends from the first passageway 2136, through the first chamber 2152 and into the first housing portion 2142. The vent line 2160 exits the first housing portion 2142 through a side port 2163 and enters the gas exchange unit 2180.

The gas exchange unit 2180 has a hollow shell structure or body 2182 connected to one side of the first housing portion 2142 and beyond the side ports 2163. The interior of the body 2182 provides a gas exchange passage 2181 that forms a section of the vent line 2160. The gas exchange passages 2181 exit the gas exchange unit 2180 through elongated slots 2186. The gas in the slot 2186 exits the body 2182 to the outside of the body through the port 2183.

As described above, the gas exchange unit 2180 is configured to be connected to different ventilation modules. In particular, the gas exchange unit 2180 may be connected to a filter unit that filters harmful gases from the CSTD before venting the gases to the atmosphere. Alternatively, the gas exchange unit 2180 may be connected to a gas storage unit that secures the harmful gas within the CSTD and prevents the release of the gas to the atmosphere. As previously mentioned, this versatility allows for the use of one base assembly design to manufacture and assemble different CSTDs, thereby improving manufacturing efficiency.

Fig. 67-74 illustrate a modular assembly that combines the base assembly 2105 with a filter unit. Referring to fig. 70 and 74, the filter unit includes a carbon filter 2166 designed to filter harmful gases in the ventilation line 2160. The plug-in receptacle 2185 forms a filter housing adapted to receive the carbon filter 2166. After the carbon filter 2166 is received into the filter housing, the cap 2169 closes the plug-in socket 2185 in a gas-tight arrangement to secure and protect the carbon filter within the gas exchange unit 2180. During operation, the harmful gases in vent line 2160 enter gas exchange passage 2181 and pass through carbon filter 2166 where they are filtered to remove toxins. The filtered gas then exits the filter housing and travels through the elongated slot 2186 to the port 2183. From there, the gas flows through an opening 2816 in the outer housing 2810 and is vented to the atmosphere.

When the filter unit is used with gas exchange unit 2180, gas exchange channels 2181 provide a bi-directional ventilation path for ventilation line 2160. That is, as described above, gas may flow in a first direction through gas exchange passages 2181 where the gas is filtered by carbon filter 2166 and released into the atmosphere. In addition, gas exchange passages 2180 allow air from the atmosphere to enter through second ports 2182 and flow through vent line 2160 in a second direction opposite the first direction to equalize pressure in the CSTD.

Carbon filters according to the present disclosure may have a variety of geometries. In this example, carbon filter 2166 is a cylindrical filter media. The gas flows in a "lateral" direction through the side wall 2167 of carbon filter 2166. This provides a longer flow path and ensures that the entire volume of the filter is used to filter harmful components, allowing more filtration and increasing the filtration capacity.

Fig. 75-84 illustrate a modular assembly that combines base assembly 2105 with inflatable reservoir 2174. For clarity, the film portion of the inflatable reservoir 2174 is omitted from the figures, with the understanding that a film such as that shown in fig. 47 and 52 may be attached.

Referring to fig. 79 and 84, the ventilation module includes a check valve 2172. The male receptacle 2185 is configured to connect to and receive a check valve 2172. The check valve 2172 is a one-way valve that allows air from the atmosphere to enter the gas exchange unit 2180 but prevents gas from exiting the gas exchange unit. Check valve 2172 is thus configured to open to allow air from the atmosphere to enter gas exchange unit 2180 and flow into vent line 2160 to equalize the pressure in the CSTD. The check valve 2172 is also configured to close in response to positive pressure in the gas exchange passage 2181, such as to prevent the escape of harmful gases to the atmosphere through the check valve when the harmful gases are released from the reservoir into the gas exchange passage.

The reservoir 2174 is configured to connect to a port 2183 of the gas exchange unit 2180 to form an inflatable bladder for storing gas. Referring to fig. 78, 79, 83 and 84, the reservoir 2174 has a hollow tubular stem 2176 defining a passageway into and out of the reservoir. The tubular rod 2176 may be inserted through an opening 2816 in the outer housing 2810 and into a slot 2186 to connect the reservoir 2174 to the gas exchange unit 2180. In this arrangement, the reservoir 2174 is configured to collect gas entering the gas exchange unit 2180 from the vent line 2160. The reservoir 2174 is also configured to discharge stored gas into the gas exchange passage 2181 and vent line 2160 to equalize the pressure as the pressure in the CSTD drops. As the reservoirs 2174 collect gas, the membrane expands, providing a visual indicator or alarm that the harmful gas is being released from one of the reservoirs and stored within the CSTD. As reservoir 2174 vents, the membrane collapses, creating a visual indicator or alarm that the pressure in the CSTD is being equalized.

When gas is released from the vial after penetration with spike connector 2130, the gas will travel through vial spike 2120 and into gas exchange unit 2180. Once inside the gas exchange unit 2180, the gas flows through the plug-in socket 2185 and is captured and collected by the reservoir 2174. The captured gas may remain stored in reservoir 2174 until a pressure drop occurs in the CSTD. When a pressure drop occurs in the CSTD, the gas stored in reservoir 2174 is released into gas exchange passage 2181 and vent line 2160 to equalize the pressure. If additional gas is required to balance the pressure, check valve 2172 is configured to allow air outside of CSTD 2100 to flow into first housing portion 2142 to balance the pressure.

Fig. 67, 71, 75 and 80 illustrate four different CSTDs that can be assembled using different modules in modular system 2100. The CSTD of fig. 67 and 75 has a vial clamp 2900A designed to attach to a 13-20mm vial. The CSTD in fig. 71 and 80 has a vial clamp 2900B designed to attach to a 32mm vial. It should be appreciated that a modular system according to the present disclosure may include other clamp modules designed to be connected to any vial size or range of sizes, as well as other types of containers.

Claims

1. A closure system delivery device, comprising:

a first adapter configured to attach to a first reservoir, the first adapter defining a first channel and including a first septum sealing an end of the first channel;

a second adapter configured to attach to a second reservoir; the second adapter includes a housing having an interior, the housing defining a second passageway and including a second septum sealing an end of the second passageway;

a carrier movable within the interior of the second adapter, the carrier defining a chamber containing at least a portion of the second septum; and

a needle disposed in the interior of the second adapter, the needle having a needle opening,

the interior of the second adapter is adapted to receive the first adapter in a telescoping manner, wherein the first adapter is insertable into the second adapter,

when the first adapter is inserted into the second adapter, the carrier is displaceable in the interior of the second adapter relative to the needle by the first adapter,

the carrier is displaceable within the second adapter between a first position in which the first septum abuts the second septum and the needle opening is sealed within the second channel, and a second position in which the first septum abuts the second septum and the needle opening is in fluid communication with the first channel to connect the first adapter and the second adapter in a fluid path open state.

2. The closure system delivery device of claim 1, comprising a releasable lock that locks the first adapter within the second adapter after insertion of the first adapter into the second adapter.

3. The closure system delivery device of claim 2, wherein the releasable lock locks the first adapter within the second adapter when the carrier is displaced to the second position.

4. A closure system delivery device according to claim 2 or 3, wherein the releasable lock comprises a first locking element located on the carrier and a second locking element located in the housing.

5. The closure system delivery device of any one of claims 2 to 4, wherein the releasable lock comprises a first locking element on the first adapter and a second locking element on the second adapter.

6. The closure system delivery device of any one of claims 2 to 5, wherein the releasable lock is released by pressing at least one side of the housing radially inward.

7. The closure system delivery device of claim 6, wherein the at least one side of the housing comprises at least one button.

8. The closure system delivery device of claim 7, wherein the at least one button is depressible radially inward to disengage a portion of the carrier from a section of the housing.

9. The closure system delivery device of claim 8, wherein the portion of the carrier comprises at least one locking lug and the section of the housing comprises at least one locking ramp within the housing.

10. The closure system delivery device of claim 7, wherein the at least one button is depressible radially inward to disengage a portion of the first adapter from a section of the second adapter.

11. The closure system delivery device of claim 10, wherein the portion of the first adapter comprises at least one flange and the section of the second adapter comprises at least one securing clip attached to the at least one button.

12. A closure system delivery device according to claim 2 or 3, wherein the releasable lock is released by rotating the second adapter relative to the first adapter.

13. The closure system delivery device of any one of the preceding claims, wherein the second adapter comprises a third septum axially spaced from the second septum.

14. The closure system delivery device of claim 13, wherein the needle opening is sealed between the second septum and the third septum when the carrier is in the first position.

15. The closure system delivery device of claims 1 to 12, wherein the second diaphragm comprises a piston having a piston head and a collapsible midsection at least partially contained in the carrier.

16. The closure system delivery device of claim 15, wherein the collapsible middle section of the piston defines a hollow core and the needle is at least partially contained within the hollow core.

17. The closure system delivery device of any preceding claim, further comprising a female luer connector rotatably mounted to the housing of the second adapter.

18. The closure system delivery device of claim 17, wherein the female luer connector comprises threads configured to mate with a threaded connection on the second container.

19. The closed system delivery device of any of the preceding claims, wherein the housing defines a locking window configured to retain the carrier in one of the first and second positions, wherein at least a portion of the carrier is visible through the locking window to visually confirm that the carrier is in the one of the first and second positions.

20. The closure system delivery device of any one of claims 1 to 18, wherein the first adapter comprises a male luer connector or a vial spike.

21. The closure system delivery device of any of the preceding claims, wherein the first adapter and the second adapter are rectangular.

22. The closure system delivery device of any one of the preceding claims, wherein the first adapter and the second adapter are cylindrical.

23. The closure system delivery device of any one of the preceding claims, wherein the needle is secured in the interior of the second adapter.

24. A closure system delivery device according to claim 2 or 3, wherein the releasable lock comprises a first locking element on the carrier and a second locking element on the first adapter.

25. The closure system delivery device of claim 24, wherein the releasable lock is released by pressing at least one side of the housing radially inward.

26. The closure system delivery device of claim 25, wherein the at least one side of the housing comprises a button.

27. The closure system delivery device of claim 26, wherein the button is depressible radially inward to disengage a portion of the housing from a section of the carrier.

28. The closure system delivery device of claim 27, wherein the section of the carrier comprises at least one locking aperture and the portion of the housing comprises at least one detent.

29. The closure system delivery device of any one of claims 24 to 27, wherein the releasable lock comprises a locking arm that extends through a slot in a wall of the housing.

30. The closure system delivery device of claim 29, wherein the locking arm is pivotally mounted in a slot on at least one hinge.

31. The closure system delivery device of claim 29, wherein the locking arm is pivotally mounted in a slot between a locked position locking the first adapter within the second adapter and a released position allowing the first adapter to be removed from the second adapter.

32. The closure system delivery device of claim 31, wherein the locking arm comprises a first end that protrudes radially outward from the wall of the housing when the locking arm is in the locked position.

33. The closure system delivery device of claim 32, wherein the first end comprises a button.

34. The closure system delivery device of any one of claims 31 to 33, wherein the locking arm comprises a second end portion that protrudes radially inwardly from the wall of the housing when the locking arm is in the locked position.

35. The closure system delivery device of claim 34, wherein the second end includes a detent that engages the carrier when the locking arm is in the locked position.

36. The closure system delivery device of claim 35, wherein the detent comprises a beveled surface and an abutment surface.

37. The closure system delivery device of claim 36, wherein the carrier comprises a locking aperture adapted to receive the pawl when the carrier is in the second position and when the locking arm is in the locked position.

38. The closure system delivery device of claim 37, wherein the locking aperture comprises an abutment edge that engages the abutment surface of the pawl when the carrier is in the second position and when the locking arm is in the locked position to prevent the carrier from moving out of the second position.

39. The closure system delivery device of any one of claims 24 to 38, wherein the second adapter comprises a third membrane axially spaced from the second membrane.

40. The closure system delivery device of claim 39, wherein the needle opening is sealed between the second septum and the third septum when the carrier is in the first position.

41. The closure system delivery device of any one of claims 24 to 40, wherein the first adapter comprises a male luer connector or a vial spike.

42. A closure system delivery device, comprising:

a carrier movable within the interior of the second adapter and attached to the second septum; and

A needle secured in the interior of the second adapter, the needle having a needle opening,

the interior of the first adapter is adapted to receive the second adapter in a telescoping manner,

when the second adapter is inserted into the first adapter, the carrier is displaceable in the interior of the second adapter relative to the needle through the interior of the first adapter,

43. The closure system delivery device of claim 42, comprising a releasable lock that locks the second adapter within the first adapter after insertion of the second adapter into the first adapter.

44. The closure system delivery device of claim 43, wherein the releasable lock locks the second adapter within the first adapter when the carrier is displaced to the second position.

45. The closure system delivery device of claim 43 or 44, wherein the releasable lock comprises a first locking element on the first adapter and a second locking element on the second adapter.

46. The closure system delivery device of any one of claims 43 to 45, wherein the releasable lock is released by pressing one side of the first adapter radially inward.

47. The closure system delivery device of claim 46, wherein the side of the first adapter comprises a button.

48. The closure system delivery device of claim 47, wherein the button is depressible radially inward to disengage a portion of the first adapter from a section of the housing.

49. The closure system delivery device of claim 48, wherein the portion of the first adapter comprises at least one locking aperture and the section of the housing comprises at least one locking ramp extending radially outwardly from the housing.

50. The closure system delivery device of claim 49, wherein the at least one locking ramp comprises a leading end, a trailing end, and a ramp surface between the leading end and the trailing end.

51. The closure system delivery device of claim 50, wherein an abutment surface in the at least one locking aperture engages the trailing end of the at least one locking ramp to lock the second adapter to the first adapter.

52. The closure system delivery device of claim 49 or 50, wherein the ramp surface comprises a straight section adjacent the leading end and a curved section extending between the straight section and the trailing end.

53. The closure system delivery device of claim 52, wherein the curved section has a compound curvature defining a concave portion and a convex portion.

54. The closure system delivery device of any one of claims 43 to 53, wherein the releasable lock comprises a locking arm that extends through a slot in a wall of the first adapter.

55. The closure system delivery device of claim 54, wherein the locking arm is pivotally mounted in a slot on at least one hinge.

56. The closure system delivery device of claim 54 or 55, wherein the locking arm is pivotally mounted in a slot between a locked position locking the second adapter within the first adapter and a released position allowing removal of the second adapter from the first adapter.

57. The closure system delivery device of claim 56, wherein the locking arm comprises a first end portion that protrudes radially outward from the wall of the housing when the locking arm is in the locked position.

58. The closure system delivery device of claim 57, wherein the first end comprises a button.

59. The closure system delivery device of any one of claims 56 to 58, wherein the locking arm comprises a second end portion, the second end portion being positioned in the slot when the locking arm is in the locked position.

60. The closure system delivery device of claim 59, wherein the second end comprises an abutment surface that engages the housing when the locking arm is in the locked position.

61. The closure system delivery device of any one of claims 42 to 60, wherein the second adapter comprises a third membrane axially spaced from the second membrane.

62. The closure system delivery device of claim 61, wherein the needle opening is sealed between the second septum and the third septum when the carrier is in the first position.

63. The closed system delivery device of any of claims 42 to 62, wherein the housing defines a locking window configured to retain the carrier in one of the first and second positions, wherein at least a portion of the carrier is visible through the locking window to visually confirm that the carrier is in the one of the first and second positions.

64. A vial spike, comprising:

a housing; and

a spike connector extending from the housing,

the housing and spike connector define a vent line and a transfer line separate from the vent line, and

the vent line includes a hydrophobic filter in the housing.

65. The vial spike of claim 64, wherein the vent line further comprises an activated carbon filter in series with the hydrophobic filter.

66. The vial spike of claim 65, wherein the housing comprises a first housing portion having a dry break coupler fluidly connected to the transfer line.

67. The vial spike of claim 66, wherein the dry-break coupler comprises a mating element for connecting the vial spike to a first fluid reservoir.

68. The vial spike of claim 66 or 67, wherein the housing comprises a second housing portion from which the spike connector extends.

69. The lancet vial of claim 68, wherein the first housing portion comprises a first cover and the second housing portion comprises a second cover configured to connect with the first cover and form a narrow space therebetween.

70. The vial spike of claim 69, wherein the first cap comprises an annular lip portion extending at least partially around a perimeter of the first cap and the second cap comprises an annular wall portion extending at least partially around a perimeter of the second cap, the annular wall portion adapted to receive the annular lip portion in a mating arrangement joining the first housing portion to the second housing portion.

71. The vial spike of claim 70, wherein the annular lip portion of the first cap comprises a dividing wall extending into the narrow space formed by the first cap and the second cap.

72. The vial spike of claim 71, wherein the dividing wall defines a first chamber in the narrow space on a first side of the dividing wall and a second chamber in the narrow space on a second side of the dividing wall.

73. The vial spike of claim 72, wherein the first chamber is fluidly connected to the vent line but not to the transfer line, and wherein the second chamber is fluidly connected to the transfer line but not to the vent line.

74. The vial spike of claim 72 or 73, wherein the hydrophobic filter is housed in the first chamber.

75. The vial spike of any of claims 72-74, wherein the spike connector defines a first channel fluidly connected to the first chamber but not fluidly connected to the second chamber and a second channel fluidly connected to the second chamber but not fluidly connected to the first chamber.

76. The vial spike of claim 75, wherein the first channel extends parallel to the second channel in the spike connector.

77. The vial spike of claim 75 or 76, wherein the transfer line comprises a particulate filter.

78. The vial spike of claim 77, wherein the particulate filter is housed in the second chamber arranged parallel to the hydrophobic filter.

79. The vial spike of any of claims 66-78, wherein the housing further comprises a third housing portion housing the carbon filter, the vent line proceeding from the first housing portion into the third housing portion and exiting to atmosphere through an outlet formed through a wall of the third housing portion.

80. The vial spike of claim 64, wherein the vent line further comprises a check valve.

81. The vial spike of claim 80, wherein the housing comprises a first housing portion having a dry break coupler fluidly connected to the transfer line.

82. The vial spike of claim 81, wherein the dry-break coupler comprises a mating element for connecting the vial spike to a first fluid reservoir.

83. The vial spike of claim 81 or 82, wherein the housing comprises a second housing portion from which the spike connector extends.

84. The lancet vial of claim 83, wherein the first housing portion comprises a first cover and the second housing portion comprises a second cover configured to connect with the first cover and form a narrow space therebetween.

85. The lancet vial of claim 84, wherein the first cover comprises an annular lip portion extending at least partially around a perimeter of the first cover, and the second cover comprises an annular wall portion extending at least partially around a perimeter of the second cover, the annular wall portion adapted to receive the annular lip portion in a mating arrangement joining the first housing portion to the second housing portion.

86. The vial spike of claim 85, wherein the annular lip portion of the first cap comprises a dividing wall extending into the narrow space formed by the first cap and the second cap.

87. The vial spike of claim 86, wherein the partition wall defines a first chamber in the narrow space on a first side of the partition wall and a second chamber in the narrow space on a second side of the partition wall.

88. The vial spike of claim 87, wherein the first chamber is in fluid connection with the vent line but not with the delivery line, and wherein the second chamber is in fluid connection with the delivery line but not with the vent line.

89. The vial spike of claim 87 or 88, wherein the hydrophobic filter is housed in the first chamber.

90. The vial spike of any of claims 87-89, wherein the spike connector defines a first channel fluidly connected to the first chamber but not fluidly connected to the second chamber and a second channel fluidly connected to the second chamber but not fluidly connected to the first chamber.

91. The vial spike of claim 90, wherein the first channel extends parallel to the second channel in the spike connector.

92. The vial spike of any of claims 87-91, wherein the transfer line comprises a particulate filter.

93. The vial spike of claim 92, wherein the particulate filter is housed in the second chamber arranged parallel to the hydrophobic filter.

94. The lancet vial of any of claims 83-93, wherein the housing further comprises a third housing portion in fluid communication with the vent line, the third housing portion connected to a flexible membrane that forms a gas storage volume between the third housing portion and flexible membrane.

95. A vial adapter, comprising:

a vial spike according to any one of claims 64 to 94; and

a vial clamp connectable to the vial spike.

96. The vial adapter of claim 95, wherein the vial clamp comprises a proximal end having a fastener mechanism configured to connect to the vial spike.

97. The vial adapter of claim 96, wherein the fastener mechanism comprises a plurality of flexible arms, each flexible arm having a barbed end.

98. The vial adapter of claim 97, wherein the flexible arm engages a portion of the housing of the vial spike to connect the vial clamp to the vial spike.

99. The vial adapter of any one of claims 95-98 wherein the vial clamp comprises at least one arcuate flange forming a socket.

100. The vial adapter of claim 99 wherein the spike connector extends into the socket and wherein the at least one arcuate flange forms a guard to protect a user from accidental sticking by spike connector.