阅读说明：本技术 用于与输注液体容器一起使用的转移装置 (Transfer device for use with infusion liquid container ) 是由 托德·M·科罗吉 吉安尼·瓜拉 王功昊 查尔斯·E·小麦考尔 杰伊·C·齐格内戈 托马斯· 于 2020-02-14 设计创作，主要内容包括：本公开提供了具有小瓶适配器和/或输注套件的转移装置,用于减少输注袋的超剂量/剂量不足。转移装置在输注液体容器和含有药品的容器之间提供了用户控制的流体转移。在一个方面中,转移装置提供了用户控制的通风,其可以在输注液体容器和含有药品的容器之间的液体转移期间使用。(The present disclosure provides a transfer device with a vial adapter and/or an infusion set for reducing over/under dosing of an infusion bag. The transfer device provides user controlled fluid transfer between the infusion liquid container and the container containing the drug. In one aspect, the transfer device provides user controlled venting that may be used during liquid transfer between an infusion liquid container and a container containing a drug.)

1. A transfer device includes a three-way connector body having

i) A vial adapter coupled to the three-way connector body for receiving a media container having a stopper, the vial adapter including a vial spike for fluid communication therewith, the vial spike including at least one vial lumen;

ii) an IV spike integral with the three-way connector body, the IV spike having a first end for insertion into an infusion liquid container, a first IV lumen, and a second IV lumen adjacent the first IV lumen and in direct fluid communication with the at least one vial lumen.

2. The transfer device of claim 1, wherein the second IV lumen is configured for isolated, direct, and continuous fluid communication through the three-way connector body.

3. The transfer device of any one of the preceding claims, wherein the vial adapter is integral with the three-way connector body.

4. The transfer device of any one of the preceding claims, wherein the vial adapter is releasably coupled with the three-way connector body.

5. The transfer device of any one of the preceding claims, wherein the at least one vial spike lumen is configurable between:

a first configuration wherein the at least one vial spike lumen is in continuous fluid communication with the first IV lumen or the second IV lumen; and

a second configuration wherein the at least one vial spike lumen is in discontinuous fluid communication with the first IV lumen or the second IV lumen upon rotation of the vial adapter relative to the three-way connector body.

6. The transfer device of any one of the preceding claims, wherein the at least one vial lumen has at least two physically separated vial lumens.

7. The transfer device of any one of the preceding claims, wherein at least one of the at least two physically separated vial lumens is in direct and continuous fluid communication with at least one of a vent, a vent filter, a one-way valve, and a fluid filter.

8. The transfer device of any one of the preceding claims, wherein at least one of the at least two physically separated vial spike lumens is in direct and continuous fluid communication with a one-way check valve.

9. The transfer device of claim 8, wherein the one-way check valve is integral with the vial adapter.

10. The transfer device of claim 7, wherein the vent filter is hydrophobic.

11. The transfer device of claim 1, wherein the three-way connector body is coupled with an infusion set.

12. The transfer device of claim 1, further comprising an IV spike adapter coupled to the three-way connector body for receiving an IV set.

13. A transfer device, comprising:

a four-way connector body, the four-way connector body comprising:

i) a first vial adapter coupled to the four-way connector body for receiving a media container having a stopper, the first vial adapter comprising a first vial spike for fluid communication therewith, the first vial spike comprising a first fluid lumen;

ii) a second vial adapter coupled to the four-way connector body for receiving a media container having a stopper, the second vial adapter comprising a second vial spike for fluid communication therewith, the second vial spike comprising a second fluid lumen;

iii) an IV spike integral with the four-way connector body, the IV spike having: a first IV lumen in direct fluid communication with the first fluid lumen; a second IV lumen adjacent to the first IV spike lumen, the second IV lumen in direct fluid communication with the second fluid lumen; and an infusion lumen providing direct fluid communication through the four-way connector body.

14. The transfer device of claim 13, wherein the infusion lumen is physically isolated from the first IV lumen and the second IV lumen by the four-way connector body.

15. The transfer device of any one of claims 13 or 14, wherein the first vial adapter further comprises a vent body and the second vial adapter further comprises a second vent body, at least one of the first vent body and the second vent body having a one-way valve or a hydrophobic filter.

16. The transfer device of claim 15, wherein the first vial spike further comprises a first vent lumen and the second vial spike further comprises a second vent lumen, wherein the first vent lumen is fluidly coupled with a first vent body and the second vent lumen is fluidly coupled with a second vent body.

17. The transfer device of claim 15, further comprising a cover that is transitionable from a hermetically sealed configuration with one of the first or second vent bodies to an unsealed configuration.

18. The transfer device of claim 15, further comprising at least one-way valve located in the vent body.

19. The transfer device of any one of claims 13-18, wherein the first vial adapter and/or the second vial adapter is integrally or releasably coupled with the connector body.

20. The transfer device of any one of claims 13-18 wherein the four-way connector body is coupled with an infusion set.

21. The transfer device of any one of claims 13-18, further comprising an IV spike adapter coupled to the four-way connector body for receiving an IV set.

22. The transfer device of any one of claims 13-18, wherein the vent lumen is fluidly isolated from the fluid lumen.

23. The transfer device of any one of claims 20-22, wherein at least one of the first vial adapter and the second vial adapter further comprises a fluid filter in fluid communication with the fluid lumen.

24. A method of transferring liquid between a sealed vial and an infusion liquid container, the method comprising:

providing a four-way connector body, the four-way connector body comprising:

a first vial adapter received by the four-way connector body, the first vial adapter comprising:

a first ventilation body;

a first spike having a proximal end and a distal end, the proximal end protruding from the first housing, the first spike having a fluid lumen and a vent lumen, the vent lumen in fluid communication with the vent body;

a shield projecting from the first vial adapter and at least partially surrounding a portion of the first spike; the shroud is configured to receive a vial or container; and

a second vial adapter received by the four-way connector body, the second vial adapter comprising:

a second ventilation main body;

a second spike having a proximal end and a distal end, the proximal end protruding from the second housing, the second spike having a fluid lumen and a vent lumen, the vent lumen in fluid communication with the vent body; and

a shield projecting from the second vial adapter and at least partially surrounding a portion of the second spike; the shroud is configured to receive a vial or container;

at least one cover coupled to one or both of the first or second vent bodies and configured to provide an air-tight sealed configuration with the respective vent body, the at least one cover being transitionable from an air-tight sealed configuration with the respective vent body to an unsealed configuration with the respective vent body;

an IV spike integral to the four-way connector body, the IV spike having a first IV lumen in fluid communication with the fluid lumen of the first vial adapter, and a second IV lumen in direct fluid communication with the fluid lumen of the second vial adapter, the second IV lumen being adjacent to the first IV fluid lumen;

establishing fluid communication between the sealed vials and the first and second vial adapters, at least one sealed vial containing a medicament;

establishing fluid communication between the IV spike and the infusion liquid container; and

manipulating the at least one cover of one or both of the first or second vent bodies into an unsealed configuration with the respective vent body.

25. The method of claim 24, wherein at least one of the first and second vent bodies comprises a one-way valve or a hydrophobic filter.

Technical Field

The present disclosure relates to transfer devices for use with infusion liquid containers (e.g., Intravenous (IV) bags, etc.). In one aspect, the transfer device comprises a user-controlled fluid that is transferred between an infusion liquid container and a container containing a drug. In one aspect, the transfer device includes user controlled venting that may be used during liquid transfer between an infusion liquid container and a container containing a drug.

Background

There are products available for use with infusion liquid containers containing an infusion liquid and having an Intravenous (IV) or administration port. The infusion liquid container may be in the form of an infusion liquid bag, an infusion liquid bottle, or the like. The transfer device is also intended for use with an additional transfer device comprising a male connector and containing a drug. Conventional transfer sets are also used with infusion sets having IV lancets and connectors. However, such conventional transfer devices are subject to vapor lock, whereby the drug cannot be completely transferred into the infusion liquid container, resulting in a scenario where highly concentrated undiluted drug may be introduced into the infusion line or the infusion liquid container is not dosed correctly. Both of these scenarios present risks and concerns.

Disclosure of Invention

In a first aspect, a transfer device is provided that includes a three-way connector body having i) a vial adapter coupled to the three-way connector body for receiving a media container with a stopper, the vial adapter including a vial spike for fluid communication therewith, the vial spike including at least one vial lumen; and ii) an IV spike integral with the three-way connector body having a first end for insertion into an infusion liquid container, a first IV lumen, and a second IV lumen adjacent the first IV lumen and in direct fluid communication with the at least one vial lumen. In another aspect, the second lumen is configured for isolated, direct and continuous fluid communication through the three-way connector body. In yet another aspect, alone or in combination with any of the previous aspects, the vial adapter is integral with the connector body. In yet another aspect, alone or in combination with any of the previous aspects, the vial adapter is releasably coupled with the connector body.

In yet another aspect, alone or in combination with any of the preceding aspects, the at least one vial spike lumen is configurable between a first configuration in which the at least one vial spike lumen is in continuous fluid communication with the first IV lumen or the second IV lumen and a second configuration in which the at least one vial spike lumen is not in continuous fluid communication with the first IV lumen or the second IV lumen when the vial adapter is rotated relative to the tee connector body.

In yet another aspect, alone or in combination with any of the previous aspects, the vial spike has at least two physically separated vial spike lumens. In yet another aspect, alone or in combination with any of the previous aspects, at least one of the at least two physically separated vial lumens is in direct and continuous fluid communication with a vent or a fluid filter. In yet another aspect, alone or in combination with any of the previous aspects, at least one of the at least two physically separated vial lumens is in direct and continuous fluid communication with a one-way check valve. In yet another aspect, alone or in combination with any of the previous aspects, the one-way check valve is integral with the vial adapter.

In yet another aspect, alone or in combination with any of the preceding aspects, the vial adapter further comprises a hydrophobic filter. In yet another aspect, alone or in combination with any of the previous aspects, the three-way connector body is coupled with an infusion set. In yet another aspect, alone or in combination with any of the previous aspects, the IV spike is coupled with an IV spike of another transfer device. In yet another aspect, alone or in combination with any of the previous aspects, the transfer device further comprises an IV spike adapter coupled to the three-way connector body for receiving an IV set.

In another example, there is provided a transfer device comprising: a four-way connector body having: i) a first vial adapter coupled to the four-way connector body for receiving a media container with a stopper, the first vial adapter including a first vial spike for fluid communication therewith, the first vial spike containing a first fluid lumen; ii) a second vial adapter coupled to the four-way connector body for receiving a media container with a stopper, the second vial adapter comprising a second vial spike for fluid communication therewith, the second vial spike comprising a second fluid lumen; iii) an IV spike integral with the four-way connector body, the IV spike having: a first IV lumen in direct fluid communication with the first fluid lumen; a second IV lumen adjacent to the first IV spike lumen, the second IV lumen in direct fluid communication with the second fluid lumen; and an infusion lumen providing direct fluid communication through the four-way connector body.

In one aspect, the infusion lumen of the IV spike is configured for isolated, direct and continuous fluid communication through the four-way connector body.

In another aspect, alone or in combination with any of the preceding aspects, the first vial adapter further comprises a vent body and the second vial adapter further comprises a second vent body, at least one of the first vent body and the second vent body having a one-way valve or a hydrophobic filter. The first vial spike further comprises a first vent lumen, and the second vial spike further comprises a second vent lumen, wherein the first vent lumen is fluidly coupled to the first vent body and the second vent lumen is fluidly coupled to the second vent body.

In another aspect, the first vial adapter and the second vial adapter are integral with the four-way connector body, either alone or in combination with any of the previous aspects. In another aspect, alone or in combination with any of the previous aspects, the first vial adapter and the second vial adapter are releasably coupled with the four-way connector body.

In another aspect, alone or in combination with any of the preceding aspects, the transfer device further comprises a cover that is transitionable from a hermetically sealed configuration with one of the first ventilation body or the second ventilation body to an unsealed configuration.

In another aspect, alone or in combination with any of the preceding aspects, the first vial adapter further comprises a vent body and the second vial adapter further comprises a second vent body, at least one of the first vent body and the second vent body having a one-way valve or a hydrophobic filter.

In another aspect, alone or in combination with any of the previous aspects, the device further comprises at least one-way valve located in the vent body.

In another aspect, alone or in combination with any of the previous aspects, the four-way connector body is coupled with an infusion set. In yet another aspect, alone or in combination with any of the previous aspects, the transfer device further comprises an IV spike adapter coupled to the four-way connector body for receiving an IV set.

In another aspect, there is provided a method of transferring liquid between a sealed vial and an infusion liquid container, the method comprising: providing a four-way connector body comprising: a first vial adapter received by the connector body, the first vial adapter comprising: a first ventilation body; a first spike having a proximal end and a distal end, the proximal end projecting from the first housing, the first spike having a fluid lumen and a vent lumen, the vent lumen in fluid communication with the vent body. A shield projecting from the first vial adapter and at least partially surrounding a portion of the first spike; the shroud is configured to receive a vial or container. The four-way connector body also has a second vial adapter received by the four-way connector body, the second vial adapter comprising: a second ventilation main body; a second spike having a proximal end and a distal end, the proximal end projecting from the second housing, the second spike having a fluid lumen and a vent lumen, the vent lumen in fluid communication with the vent body. A shield projecting from the second vial adapter and at least partially surrounding a portion of the second spike; the shroud is configured to receive a vial or container.

The four-way connector body also includes at least one cap coupled to one or both of the first vent body or the second vent body and configured to provide an air-tight sealed configuration with the respective vent body, the at least one cap being transitionable from the air-tight sealed configuration with the respective vent body to an unsealed configuration with the respective vent body, and an IV spike integral with the four-way connector body, the IV spike having a first IV lumen in fluid communication with the fluid lumen of the first vial adapter and a second IV lumen adjacent to the first IV lumen and in direct fluid communication with the fluid lumen of the second vial adapter.

The method further includes establishing fluid communication between the sealed vial and the first and second vial adapters and establishing fluid communication between the IV spike and the infusion liquid container. The method includes manipulating the cover of one or both of the first vial adapter or the second vial adapter into an unsealed configuration with the vent body cover to provide venting.

In another example, alone or in combination with any of the previous examples, at least one of the first and second vent bodies comprises a one-way valve or a hydrophobic filter.

Drawings

The present disclosure will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which like parts are similarly numbered, and in which:

fig. 1A is an exploded view of a transfer device as disclosed and described in the present disclosure;

FIG. 1B is a partially exploded view of the transfer device of FIG. 1A;

FIG. 1C depicts a cross-sectional view of the transfer device of FIG. 1A along line 1C-1C;

fig. 2A is a side view of a transfer device as disclosed and described in the present disclosure;

FIG. 2B is an opposite side view of the transfer device of FIG. 2A;

FIG. 2C is a top plan view of the transfer device of FIG. 2A;

FIG. 2D depicts a partial cross-sectional view of the transfer device of FIG. 2B along line 2D-2D;

FIG. 3A depicts a perspective view of a fluid access controlled transfer device having an infusion liquid bag and a medicament container;

FIG. 3B depicts an exploded view of the transfer device of FIG. 3A;

FIG. 3C depicts a perspective view of the on/off position of the transfer device of FIG. 3A, respectively;

FIG. 3D depicts a cross-sectional view of the transfer device of FIG. 3A along line 3D-3D in a closed position;

FIG. 4 depicts a perspective view of a dual container transfer device as disclosed and described in the present disclosure;

FIG. 5 is an exploded view of a dual container transfer device as disclosed and described in the present disclosure;

FIG. 6A depicts a top view of the dual container transfer device of FIG. 4;

FIG. 6B depicts a cross-sectional view of the dual container transfer device of FIG. 6A along line 6B-6B;

FIG. 7A depicts a perspective view of the dual container transfer device of FIG. 4 without the IV spike and the vial container spike cover;

FIG. 7B depicts an exploded top perspective view of the dual container transfer device of FIG. 4 showing an IV spike lumen;

FIG. 8A is a perspective view of a dual container transfer device with user controlled venting as disclosed and described in the present disclosure;

FIG. 8B is a perspective view of a dual container transfer device with a one-way valve as disclosed and described in the present disclosure;

FIG. 9 is an exploded view of the dual container transfer device of FIG. 8A as disclosed and described in the present disclosure;

FIG. 10A depicts a top view of the dual container transfer device of FIG. 8A;

FIG. 10B depicts a cross-sectional view of the dual container transfer device of FIG. 10A along line 10B-10B;

11A, 11B, and 11C depict an exemplary cap assembly and user-controlled cap as disclosed and described in this disclosure;

fig. 12 depicts an administration set comprising an IV bag/infusion liquid bag, an exemplary transfer device as disclosed and described in the present disclosure, a medicament/medium vial or container, and an infusion set; and

fig. 13 depicts an administration set comprising an IV bag/infusion liquid bag, an exemplary dual container transfer device as disclosed and described in the present disclosure, a plurality of medicament/medium vials or containers, and an infusion set;

fig. 14 depicts an administration set comprising an IV bag/infusion liquid bag, an exemplary dual container transfer device with user controlled venting as disclosed and described in this disclosure, a plurality of medicament/medium vials or containers, and an infusion set.

Detailed Description

The present disclosure provides a transfer device that allows for efficient and substantially complete transfer of a drug or medicament from a medicament container or vial to an infusion liquid container while reducing or eliminating the possibility of medicament remaining in the medicament container or diluted medicament being present in the infusion line.

The term "fluid" as used herein refers to a gas, a liquid, or a combination of a gas and a liquid. Throughout this specification, the term "liquid" as used herein includes suspensions, oil-in-water emulsions, water-in-oil emulsions, and liquids with or without dissolved, dispersed, or contained solids, regardless of the size or amount of solids present.

As understood by those of ordinary skill in the art, fluid transfer devices are provided for introducing fluid from one vessel to another, while fluid control devices include flow control mechanisms for diverting, metering, or interrupting flow between at least two flow paths.

Throughout this specification, the term "medium" includes solids, semi-solids, emulsions, liquids, or combinations thereof. For example, the medium may be a lyophilized drug, a suspended drug, or an emulsion of a drug.

Throughout this specification, unless otherwise indicated, the terms "shroud" and "skirt" are used interchangeably and do not limit the scope of any claims either explicitly or implicitly.

Throughout this application, unless otherwise indicated, the phrases "medicament container," "vial," "medicament vial/container," and "media container" may be used interchangeably without any express or implied limitation as to the scope of any claim.

The following is a description of associated features and drawings of each aspect of the apparatus and methods disclosed and described herein.

Fig. 1A, 1B, and 1C depict an exploded view, a partially exploded view, and a cross-sectional view along line 1C-1C, respectively, of the transfer device 100. Transfer device 100 includes a three-way connector body 150, the three-way connector body 150 configured for coupling with vial adapter 101. Projecting from the three-way connector body 150 is an IV spike 122, which is shown with a removable cap 102. The IV spike 122 is configured for insertion into a liquid infusion container and has two lumens 123, 124 that are physically separated by a lumen wall 122 a. Projecting from and coupled to the opposite end of the three-way connector body is a tapered opening 146, the tapered opening 146 being received by the open end 145 of the infusion port 143 that terminates in a twist-off closure member 144.

The IV spike 122 protrudes from a surface 125, which surface 125 provides a mechanism for attaching the cap 102 and functions to terminate insertion of the IV spike into a liquid infusion container.

Vial adapter 101 includes a distal annular rim 115 surrounding vial spike 200 having a single central fluid lumen 131 and supporting a retaining/receiving projection or finger (116). The vial spike 200 is shown with a protective cap 202. In one aspect, vial adapter 101 has four fingers 116, shown in FIG. 1B, positioned generally opposite each other, defining four openings by four segments 120 connecting distal annular edges (115). Other shield configurations may be used. The vial spike 200 is approximately integral with the housing and is open near its distal end for communication with the vial. The fluid lumen 131 is open on the side of the lancet or near the distal end of the lancet. The lancet 200 can be constructed of plastic, metal, or a composite material. The spike 200 is designed such that it readily pierces the closure of a vial or drug container, e.g., is pointed and/or beveled to facilitate insertion.

Referring to the partially exploded view of fig. 1B and the longitudinal cross-section of fig. 1A along line 1C-1C as shown in fig. 1C, vial adapter 101 includes a tapered connector 128 protruding from an annular seat 130, the connector 128 being reversibly receivable by a female connector 127 of connector body 150. The connector body 150 has a receiving opening 129 corresponding to the wing member 130a of the vial adapter 101. The connector 128 and the connector 127 may be permanently coupled, such as by adhesive, or sonic or solvent welding.

When vial adapter 101 is coupled with connector body 150, tapered connector 128 provides fluid communication via lumen 131, which lumen 131 is in direct and continuous fluid communication with lumen 124 of IV spike 122. When vial adapter 101 is coupled with connector body 150, lumen 131 is not in direct and/or continuous fluid communication with lumen 123 of IV spike 122 so as to substantially isolate or prevent fluid communication therebetween.

Referring to fig. 2A, 2B, which respectively depict a side view, an opposite side view, a top plan view, and a partial cross-sectional view along line 2D-2D of a transfer device 100 'having a vial adapter 201, the transfer device 100' has the same connector body 150, IV spike 122, cap 102, and infusion port 143 components, but differs from the transfer device 100 in that the vial adapter 201 includes a vent hole 402 in a vent housing 409 of the adapter 201 for one-way communication with the atmosphere. FIG. 2D shows only a cross-sectional view of the vial adapter along section line 2D-2D of FIG. 2D. In one example, the vent 402 includes a user-actuated cover (not shown), which will be described in more detail below. An antimicrobial filter 407 may be used to filter the air entering the device 100'. In one example, antimicrobial filter 407 is hydrophobic to prevent or eliminate liquid from exiting transfer device 100, 100'.

The vent provides additional security during use of the disclosed transfer device by relieving pressure that may build up in the fluid and media containers during transfer of liquid volumes via the squeeze infusion container, and by preventing or eliminating an airlock or fluke lock during transfer that would otherwise result in undiluted medicament being introduced into the transfer line (in excess) or partially diluted medicament being introduced into the transfer line (in under-dosed). In one example, user controlled vents are provided for ventilation. In another example, a one-way valve is provided for allowing air into the device while preventing or eliminating the release of liquid volume through the device during squeezing of the infusion container.

Alternatively, one-way fluid communication may be applied by any mechanism capable of restricting fluid flow, such as a check valve. The check valve may be used to provide substantially one-way fluid transport through the vent lumen of the vial adapter. The check valve may be assembled in a manner that vents air from the transfer device that is allowed to move out of the IV bag (during squeezing by the user) to the atmosphere, thereby reducing or eliminating an air or liquid lock during reconstitution/transfer. The opening may be in communication with a check valve disposed in cooperative relationship with the liquid infusion container for providing pressure equalization within the transfer set, the liquid infusion container and the drug container to facilitate effective and substantially complete mixing and/or transfer of the contents of the vial to the liquid infusion container. In one example, an air check valve, or a valved vent and/or a dual lumen vial spike 401 is connected to vial adapter 201 or is integral with vial adapter 201. Exemplary one-way valves include, for example, a LOGICA air valve (Ordenburg, Germany), such as the air valve V2 OOO.

The vial spike 200 is approximately integral with the housing and is open near its distal end for communication with the vial. The spike of vial spike 200 includes at least two lumens 412, 413, both of which can be open near the distal end of the spike and function independently of each other. The openings in lumens 412, 413 may be at the distal end of vial spike 200, the side of the spike, or one lumen opening may be at the distal end of the spike and the other lumen opening may be on the side of the spike. The relative positions of the openings of lumens 412, 413 near the distal end of vial spike 200 may be the same or different. The vial spike 200 may be constructed of plastic, metal, or composite material. The vial spike 200 is designed such that it readily pierces the closure of a vial or drug container, e.g., is pointed and/or beveled to facilitate insertion.

Vial spike 200 has a fluid lumen 412 in direct and continuous fluid communication with lumen 131, while vent lumen 413 is in direct and continuous fluid communication with vent hole 402 and not in direct fluid communication with lumen 131. Fluid lumen 412 is physically isolated from ventilation lumen 413 by lumen wall 401, and thus, fluid communication between lumen 412 and lumen 413 is restricted or prevented. In one example, vial adapter 201 has a tapered male connector 128, and tapered male connector 128 is received by a female connector (not shown) of connector body 150. In another example, vial adapter 201 has a female connector 127, as shown in fig. 2D, that is received by a male connector of connector body 150. In one example, vial adapter 201 has a tapered male connector 128 that is received by female connector 127 of connector body 150. Gripping surface 126 is shown on vial adapter 201 for a user to grip the vial adapter, and parallel features on the surface act as gripping mechanisms.

The transfer device 100' with user controlled venting vial adapter and filter disclosed herein demonstrates that pressure loading against the flow direction has no effect on the function of the valve and/or the valve effectively prevents the bacterial filter from being wetted. In contrast, vial adapters with filters without air or check valves have been found to quickly saturate the filter under pressure, thereby reducing its effectiveness. The air valve (or air check valve) 402 of the transfer device 100' disclosed herein avoids or eliminates saturation of the filter under pressure.

Referring to fig. 3A, 3B, 3C and 3D, a side view and an exploded view of transfer device 300 with vial adapter 201B and a partial cross-sectional view along line 3D-3D, respectively, are depicted. This transfer device 300 has the same connector body 150, IV spike 122, cap 102, and infusion port 143 components, but differs from transfer devices 100 and 100' in that vial adapter 301 includes flow control between vial adapter 201b and lumen 123 of IV spike 122 via female connector 127.

Thus, as shown in fig. 3A, 3B, 3C, and 3D, vial adapter 301 provides for controlled fluid communication into and out of the vial. The transfer device 300 as shown provides unvented flow control between the medicament container and the IV spike 122 and/or infusion port 143. The lancet 200 is shown configured with a fluid lumen 133 with an optional offset point. Alternatively, the transfer device 300 may be configured to provide flow control in combination with the vent by combining the above-described features of the transfer device 100'.

As shown in fig. 3B, vial adapter 301 comprises housing 210. The housing 210 has a protruding tapered male connector 231, the male connector 231 having a fluid path 233. The tapered connector 231, which is partially surrounded by the protruding wall 226 of the housing 210, is received by the protruding female connector 127 of the connector body 150. Alternatively, the fluid lumen of the vial adapter may include a male or female luer connector for attachment to a corresponding mating connection of the housing 210 and the connector body 150. Other connections may be used, such as a threaded connection, for example the vial adapter may be replaced with a needleless connector for accessing the fluid path through the syringe.

Positioned between the fixed housing 210 and the rotatable vial adapter 201b is a sealing mechanism 335 comprising an outer annular ring 205 and an inner annular ring 206, with the opening 209 positioned between the relatively fixed housing 210 and the rotatable vial adapter 201 b. The combination of the outer annular ring 205 and the inner annular ring 206 defines a crescent-shaped opening 207, the crescent-shaped opening 207 being aligned with a raised crescent-shaped surface 208 of the rotatable vial adapter 201 b. An outer annular ring 205 is received by the seat 204 around the raised crescent-shaped surface 208 to provide a fluid seal. The inner annular ring 206 and the opening 209 are rotatably transitionable from a first configuration in which the at least one vial spike lumen 133 of the vial spike 200 is in continuous fluid communication with the lumen 124 of the IV spike 122 to a second configuration in which the at least one vial spike lumen is not in continuous fluid communication with the lumen 124 of the IV spike 122 when the vial adapter is rotated relative to the connector body about the longitudinal axis of the vial spike 200 to prevent fluid from entering the fluid path of the spike lumen 133 of the vial spike 200, as shown in fig. 3C and 3D. The sealing mechanism provides safe fluid control regardless of shield position. Pressure loading against the direction of flow has substantially no effect on the fluid control function of the device 300. The sealing mechanism is closed in the standby position. No backflow is required to reposition the housing 210.

Indicia (118a, 118b, 118c) are shown disposed on the rotatable vial adapter 201b and the relatively stationary housing 210 to assist in obtaining proper positioning of the rotatable vial adapter for selective control of the pathway of fluid communication between the IV bag/fluid path and the medicament/media container. In one aspect, a symbol or color may be used as a marker. Other indicia may be used, such as raised or recessed regions. A keyway (211) for orientation control of the vial adapter 201b and for preventing release of the flow controller from the housing 210 is shown.

Double-container transfer device

Fig. 4 depicts a perspective view of a dual container transfer device 400. Fig. 5 is an exploded view of the dual container transfer device 400. Fig. 6A depicts a top view of the dual container transfer device 400, and fig. 6B depicts a cross-sectional view of the dual container transfer device 400 along line 6B-6B. Fig. 7A depicts a perspective view of the dual container transfer device of fig. 4 without the IV spike and vial container spike cover, and fig. 7B is an exploded top view of the device 400 showing the lumens 323, 324a and 324B of the IV spike 322.

As shown in fig. 4, 5, 6B, and 7A-7B, dual container apparatus 400 has a similar structure to apparatus 100, but with the addition of the ability to independently access more than one vial container. In one example, the apparatus 400 provides for simultaneous access to more than one vial container.

Accordingly, device 400 includes a four-way connector body 350, the four-way connector body 350 configured for coupling with two vial adapters 101a, 101 b. The coupling of the connector body 350 to each of the two vial adapters 101a, 101b is similar to the coupling of the device 100 described above. Projecting from a face 325 of the four-way connector body 350 is an IV spike 322, which is shown with a removable cap 102. IV spike 322 is configured for insertion into a liquid infusion container and has three lumens 323, 324a and 324 b.

Projecting from and coupled to the opposite end of the four-way connector body is a tapered opening 346, the tapered opening 346 being received by the open end 145 of the infusion port 143 that terminates in a twist-off closure member (twist-off member) 144. Lumen 323, along its length from the distal end of spike 322 to tapered opening 346, is physically separated from lumens 324a and 324b by lumen wall 322 a.

Each vial adapter 101a, 101b includes a tapered male connector 328a, 328b reversibly receivable by a female connector 327a, 327b, respectively, of the connector body 350, however, this arrangement may be provided with a reverse (male/female) connector. The connector body 350 has receiving openings 129 corresponding to the wing members 130b of the vial adapters 101a, 101 b. The connectors 328a, 328b and the connectors 327a, 327b may be permanently coupled, such as by adhesive, solvent, or sonic welding.

When either vial adapter 101a, 101b is coupled with connector body 350, tapered connectors 328a, 328b provide direct and continuous fluid communication with lumens 324a, 324b, respectively, of IV spike 322 via lumens 331a, 331 b. However, when one vial adapter 101a, 101b is coupled with connector body 350, lumen 131 is not in direct and/or continuous fluid communication with lumen 324a or 324b of IV spike 322 so as to substantially isolate or prevent fluid communication therebetween.

Lumens 324a and 324b are physically separated from each other along their entire lumen length. Lumen 324a is fluidly coupled to fluid lumen 331a of connector body 350 and lumen 133a of vial adapter 101 a. Likewise, lumen 324b is fluidly coupled to fluid lumen 331b of connector body 350 and lumen 133b of vial adapter 101 b. This configuration accordingly provides a fluid channel that is isolated from either of the vial spike 200 and the respective IV fluid lumens 324a, 324 b. One or more vial adapters 101a, 101b may independently include a vent and/or check valve for one-way communication with the atmosphere, as described above for device 100'.

User controlled ventilation

Fig. 8A-10B relate to devices 500a, 500B having user-controlled ventilation. In one example, venting is provided by a vent hole and optional vent filter located in the vent body 305 of the housing 311a, 311b that is in fluid communication with the vent lumen of the one or more vial spike 200, wherein at least one vent body 305 has a user controlled vent cover 375 that can be transitioned from a first state in which the vent hole is closed to a second state in which the vent hole is open to the ambient environment, as described below. In another example, venting is provided by a one-way valve vent located in at least one venting body 305, and optionally one or both of the aforementioned one-way valves 395 have a user-controlled venting cover 375 that can transition from a first state in which the one-way valve is closed to a second state in which the one-way valve is open to the ambient environment, as described below.

Referring to fig. 8A, a perspective view of an exemplary device 500A is shown in a fully assembled state, wherein controlled ventilation is in a first state for vial adapter 101a, and wherein controlled ventilation is in a second state for vial adapter 101B, which is discussed in more detail below with reference to fig. 9 and 10A-10B of an exploded view of display device 500. Fig. 10A is a top plan view of device 500, showing section line 10B-10B. Figure 10B is a cross-sectional view of device 500 taken along section line 10B-10B.

Referring to fig. 8A, a perspective view of an exemplary device 500a is shown in a fully assembled state. Wherein the controlled ventilation is in a first state for vial adapter 101a of housing 311a and wherein the controlled ventilation is in a second state for vial adapter 101B of housing 311B, which is discussed in more detail below with reference to fig. 9 and 10A-10B of an exploded view of display device 500. The device 500a is similar to the device 400, but has a controllable vent cover 375 coupled to one of the vent bodies 305 of the housings 311a and 311 b. In one example, a controllable vent cover 375 (not shown) is coupled to one of the vent bodies 305 of the housings 311a and 311 b.

Referring to fig. 8B, a perspective view of an exemplary device 500B is shown in a fully assembled state. Wherein controlled venting is provided by a one-way valve 395 located in the vent body 305. Device 500b is similar to device 500a, but has a one-way valve 395 located in the vent body 305 of one or both of the housings 311a 'and 311 b'. The apparatus 500b is shown without the cover 375, however, the cover 375 may be employed as described for the apparatus 500 a. The device 500b may have a one-way valve 395 and a controllable vent cover 375 (not shown). In another example, the device 500b can include a controllable vent cover 375, the controllable vent cover 375 being coupled to one of the vent bodies 305 of the housing 311a 'and a one-way valve 395 being coupled to the vent body 305 of the housing 311 b'.

In one example, a controllable vent cover 375 (not shown) is coupled to one or both of the vent bodies 305 of the housings 311a and 311b for covering the one-way valve 395 and preventing venting. In one example, a controllable vent cover 375 is coupled to the two vent bodies 305 of the housings 311a and 311b for closing the two one-way valves 395. Although not shown, the device 500a or 500b can be configured to include one vent body 305 having a one-way valve 395 and another vent body having only a vent filter with a controllable vent cover 375. Although not shown, alternatively, the device 500a or 500b can be configured to include one vent body 305 with a one-way valve 395 having a controllable vent cover 375 and another vent body with a vent filter having a controllable vent cover 375.

Referring to fig. 9, 10A and 10B, there is shown a device 500A comprising a four-way connector body 350 having housings 311a and 311B configured for coupling with two vial adapters 101a, 101B. The device 500a is similar to the device 400, but has a controllable vent cover 375 provided in each housing 311a and 311 b. The coupling of the connector body 350 to each of the two vial adapters 101a, 101b is similar to the coupling of the device 400 described above. Projecting from a face 325 of the four-way connector body 350 is an IV spike 322, which is shown with a removable cap 102, the IV spike 322 being configured for insertion into a liquid infusion container and having three lumens 323, 324a and 324 b. Each of the two vial adapters 101a, 101b includes a spike 200, each spike containing at least two lumens (e.g., fluid lumen 133a, 133b and vent lumen 134a, 134b), each spike configured for piercing a pierceable septum of a container closure element, such as a medicament vial, and for providing fluid communication through the device 500.

In one example, both housings 311a, 311b include an anti-airlock feature (not shown), for example, to prevent airlock if fluid enters the void space between the vent filter 304 and the vent lumens 134a, 134 b. For example, if the vent is submerged, extending the orifice height with the anti-airlock feature helps to evacuate fluid in an inverted orientation. In another example, vent lumens 134a, 134b have their openings in spike 200 vertically indexed with the openings in fluid lumens 133a, 133b such that when device 100 is engaged with a container and inverted, the openings in vent lumens are above the liquid level of the container, while the openings in vent lumens 134a, 134b are configured below the above-mentioned liquid level and are configured to receive liquid adjacent the septum of the container such that a maximum amount of liquid can be transferred from the container through spike 200.

The vent body 305 may be constructed of a rigid plastic such as polycarbonate, polypropylene, cyclic olefin copolymer, and the like. In one example, the vent body 305 is configured to receive a one-to-one valve 395 or a vent housing with a filter 304.

Fig. 10B is a cross-sectional view taken along section line 10B-10B of fig. 10A showing housings 311a, 311B coupled to coupler body 350, respectively providing independent fluid communication between fluid lumens 133a, 133B of spike 200 and fluid lumens 324a, 324B of IV spike 322. Connector body 350 as shown is a four-way connector body to which housing 311a including first vial adapter 101a is coupled for receiving a media container with a stopper. First vial adapter 101a includes a first vial spike 200 having a first fluid lumen 133 a. Second vial adapter 101b, which includes second vial spike 200, is coupled to connector body 350 and is also used to receive a media container having a stopper. Second vial spike 200 has a second fluid lumen 133 b. The devices 500a, 500b also include an IV spike 323 integral with the connector body 350. IV spike 323 has a first IV fluid lumen 324a in direct fluid communication with first fluid lumen 133a of spike 200 of vial adapter 101 a. Second IV fluid lumen 324b of IV spike 323 is adjacent first IV spike lumen 324a and second IV fluid lumen 324a is in direct fluid communication with second fluid lumen 133b of vial spike 200 of vial adapter 101 b. The IV spike has an infusion lumen 323 that is in direct fluid communication with the connector body and the central fluid lumen 131.

This arrangement provides isolation of the fluid paths of fluid lumens 133a and 324a from the fluid paths of fluid lumens 133b and 324 b. In addition, the fluid lumen 323 pathway leading to the central lumen 141 is physically isolated from the fluid lumen 324a, 324b, 133a, and 133b pathways.

Each vial adapter 101a, 101b is shown with a female connector 372 that is receivable by the male connector 382 of the connector body 350, however, this configuration may be provided with a reverse (male/female) connector coupling. Each vial adapter 101a, 101b of device 500 may be permanently or reversibly connected to connector body 350.

The vent body 305 has an opening 307 in fluid communication with the vent lumen of the lancet 200, the opening 307 being configured to receive the cover assemblies 375a, 375 b. As shown in fig. 11A, 11B, the lid assemblies 375a, 375B include a lid body 385 sized to be received by the opening 307 of the vent body 305. The cap body 385 defines an opening 377 therethrough, and an end 390 of the cap body is coupled to the cap 375 via a hinge 355, shown in an open configuration. In one example, the opening 377 is configured to receive the filter 304 or the one-way valve 395 and provide an airtight seal therewith. In another example, opening 377 is configured to receive one-way valve 395 and provide an airtight seal therewith, and does not have a lid 375 or hinge 355, as shown in fig. 8B. Fig. 11C depicts the lid assemblies 37a, 37b with the lid 375 in the closed configuration and the opening 377 providing an airtight seal therewith.

In one example, the cover assemblies 375a, 375b are generally cylindrical in shape. In one example, the cap 375 has an annular wall 365, the annular wall 365 being configured to be received by the opening 377 of the cap body 385 and provide an airtight seal therewith. The cover body 385, cover 375, and annular wall 365 may be constructed of polyethylene, polyethylene copolymer, polypropylene copolymer, rubber, silicone, or thermoplastic elastomer.

In one example, the cover 375, the wall 365, and the cover body 385 are constructed of the same material that is softer and more pliable (lower durometer) than the vent body 305, e.g., for press-fitting with the opening 307 of the vent body 305, solvent bonding, etc. The vent body 305, openings 307, 377, and wall 365 may be tapered.

The vent cover 375 is configured to transition from a first state to a second state. In the first state, the wall 365 is in a sealed and air-tight relationship with the opening 377. In the second state, the wall 365 is moved away from the opening 377 such that a fluid path is formed through the vent body 305 between the opening 377 and the vent lumens 134a, 134b of the lancet 200, respectively. In one example, the transition of the vent cover 375 from the first state to the second state is reversible. In another example, the transition of the vent cover 375 from the first state to the second state is irreversible. In one example, the cover 375 is completely removable from the vent body 305. In another example, the hinge 355 of the vent cover 375 is configured to allow the vent cover 375 to transition from the first state to the second state and maintain a physical connection between the cover and the vent body 305. Tab feature 360 allows a user to easily transition vent cover 375 from the first state to the second state, for example, using a finger or thumb of one hand.

The vent body 305 of the first housing 311a receives the cover body 385. In the first state, the opening 377 of the cap body 385 receives the wall 365 of the vent cap 375, thereby providing a sealing relationship. Fluid communication between the vent lumens 134a, 134b and the ambient environment is controlled via the vent cap 375, wherein in a first state, fluid access to the ambient environment is sealed by the vent body 305 and the vent lumens 134a, 134b of the spike 200, wherein in a second state, fluid access to the ambient environment is provided through the vent body 305 and the opening 307 and via the vent lumens 134a, 134b of the spike 200.

An optional vent filter 304 is also shown with the vent body 305. The vent filter 304 may be constructed of any suitable material having micron porosity, hydrophobicity, and efficiency for a given application. Typical ranges for the microporosity of the vent filter are between 0.02uM and 150uM (microns). In one aspect, the ventilation filter 304 is disc-shaped. Other shapes may be used for the ventilation filter 304.

During the fluid removal/transfer process, the particulates may be present in the vial or mixed in the medicament. The types of particles that may be present in the vial include: pharmaceutical precipitates, lipids, undissolved solids, crystals of pharmaceutical agent components, glass, plastic and rubber fragments, membrane particles, and various other types of contaminants. These particles may be of various sizes and shapes, and depend on the agent, hydrophilic and/or hydrophobic, and/or partially or fully ionized salts. Furthermore, the insertion of the vial into the spike may cut or core off a small portion of the stopper of the vial. These particles are often of a size that is visible under a microscope and are not noticed. Microparticles injected into a patient may cause complications, such as phlebitis, organ damage, and vessel occlusion. This creates the necessary technical problem of fluid filtration alone or in combination with controlled ventilation.

Accordingly, a solution to the above technical problem is solved by incorporating in the device 100, 100', 300 or 500a fluid filtration function as described in commonly assigned U.S. patent No. 9,585,812, the disclosure of which is incorporated herein by reference.

Dosing kit

Fig. 12 depicts an administration set comprising an IV bag/infusion liquid bag, an exemplary transfer device 300 as disclosed and described in the present disclosure, a medicament/medium vial or container, and an infusion set. In general, the devices (100, 100', 300), infusion fluid bags 10, media containers 20, and conventional infusion sets 18 disclosed herein are used in combination, for example, as a kit 50. The use of the kit 50 is as follows: the IV spike 122 is sealingly inserted into the IV port 16 (or 14) and the vial adapter 101, 201, 301 is snap-fit onto the media container 20, wherein the vial spike penetrates the media container stopper 21 to allow introduction of the infusion liquid 12 of the infusion liquid bag 10. Such addition is typically accomplished by squeezing the infusion liquid bag 10 to force the infusion liquid 12 into the medium container 20, and then inverting the infusion liquid bag 10 to facilitate transfer of the vial contents. When the medium container 20 includes the lyophilized medicament 22, the infusion liquid will reconstitute the medicament and may include several cycles of forcing the infusion liquid into the medium container 20 and expelling the vial contents into the IV bag 10. Then, after removal of the twist-off closure member 144, the infusion line spike 19 of the infusion set 18 is sealingly inserted into the transfer set infusion port 143.

Although not shown, the transfer devices 100, 100', 300 described thus far all have an IV port 143, and such devices may be configured with an integral infusion set, rather than connecting tubing directly to the IV port 143 at the IV port.

The use of the transfer device 300 is similar to the use of the transfer devices 100, 100' in adding a medicament additive to the infusion liquid bag 10, but the device 300 provides access control between the vial 20 and the infusion liquid bag 10 and/or the infusion set 18. Thus, referring to FIG. 3C, after vial 20 is connected to vial adapter 301, housing 210 may be rotated about a longitudinal axis (co-aligned with section line 3D-3D). In the first configuration, the device 300 has a path 233 that provides access to the spike lumen 133 for allowing fluid communication between the device 300 and the vial 20. In the second configuration, the device 300 has a path 233 that is not aligned with the spike lumen 133 for preventing fluid communication between the device 300 and the vial 20.

Fig. 13 depicts an administration set that includes an IV bag/infusion liquid bag, an exemplary dual container transfer device 400, a multi-dose/media vial or container, and an infusion set. The use of the transfer device 400 is similar to the use of the transfer devices 100, 100 'in adding a medicament additive to the infusion fluid bag 10, but the device 400 provides the user with the option of using (accessing) one or both of the media containers 20, each having a releasable cap 202a, 202b with an annular seat 75 that seals the respective vial spike 200a, 200b, and if one of the caps 202a, 202b is not removed, the device 400 functions as the device 100, 100' described above. In one example, the device 400 provides for the use of containers 20 containing different medicaments and/or provides a dual medicament dosing scheme. The device 400, infusion liquid bag 10, two media containers 20 and conventional infusion set 18 disclosed herein are used in combination, for example, as a kit 50 a. The use of the kit 50a is as follows: the IV spike 322 is sealingly inserted into the IV port 16 (or 14) and the vial adapter 101a and/or 101b is snap-fit onto the corresponding media container 20. Wherein the respective vial spike 200a, 200b penetrates the media container stopper 21 to allow introduction of the infusion liquid 12 of the infusion liquid bag 10 into each container 20. This addition is typically accomplished by squeezing the infusion liquid bag 10 to force the infusion liquid 12 into the medium container 20, and then inverting the infusion liquid bag 10 to facilitate transfer of the vial contents. When the medium container 20 comprises a lyophilized medicament, the infusion liquid will reconstitute the medicament, and may include several cycles of forcing the infusion liquid into the medium container 20 and expelling the vial contents into the IV bag 10. Then, after removal of the twist-off closure member 144, the infusion line spike 19 of the infusion set 18 is sealingly inserted into the transfer set infusion port 143.

Fig. 14 depicts an administration set comprising an IV bag/infusion liquid bag, an exemplary dual container transfer device 500a with user controlled venting as disclosed and described in the present disclosure, a plurality of medicament/medium vials or containers, and an infusion set. The device 500, the infusion fluid bag 10, the two medium containers 20 and the conventional infusion set 18 are used in combination, for example, as a kit 50 b.

The use of the transfer device 500a and kit 50b is similar to the use of the transfer device 400 and kit 50a in adding a pharmaceutical additive to the infusion fluid bag 10, but the device 500a provides ventilation independently between one or both of the media containers 20 and the infusion fluid bag 10 and/or infusion set 18. Thus, a method of transferring liquid between a sealed vial and an infusion liquid container is provided as follows.

As shown in fig. 14, the four-way connector body 350 has: a first vial adapter 101a received by the connector body, the first vial adapter comprising a vented body 305 having a cover 375, the cover 375 of the vial adapter 101a transitionable from a hermetically sealed configuration with a corresponding vented body to an unsealed configuration, the cover configured for reversibly hermetically sealing the vented body; and a lancet 200 having a proximal end and a distal end, the lancet having a fluid lumen 133a and a vent lumen 134a in fluid communication with the vent body. The cover 375 of the adapter 101a is shown in a configuration that provides an airtight seal with the vent body. A shroud 115 projects from first vial adapter 101a and at least partially surrounds a portion of spike 200, the shroud being configured to receive vial or container 20.

The four-way connector body 350 further receives a second vial adapter 101 b. The second vial adapter 101b includes a vent body 305 having a cover 375. The lid 375 of vial adapter 101b may be transitioned from the hermetically sealed configuration with the respective vent body to the unsealed configuration. Vial adapter 101b includes spike 200 having fluid lumen 133b and vent lumen 134b, which is in fluid communication with the vent body. Shroud 115 protrudes from second vial adapter 101b and at least partially surrounds a portion of spike 200. Shroud 115 of adapter 101b is configured to receive additional vials or containers.

As shown, the cover 375 of the adapter 101b is shown in an unsealed configuration with the vent body 305, however, one or both of the covers 375 of the first vial adapter or the second vial adapter may be in a hermetically sealed configuration or unsealed configuration with the respective vent body.

The four-way connector body 350 further includes an IV spike 322 integral with the connector body having a first IV fluid lumen 324a in fluid communication with the fluid lumen 133a of the first vial adapter 101a and a second IV fluid lumen 324b (adjacent the first IV fluid lumen) in direct fluid communication with the fluid lumen 133a of the second vial adapter 101 b. The vial adapter is snap-fit onto the respective media container 20 with the vial spike 200 penetrating the media container stopper 21 to allow introduction of the infusion liquid 12 of the infusion liquid bag 10 into each container 20. Fluid communication between the sealed vial and the first and second vial adapters is performed and fluid communication between the IV spike 322 and the infusion liquid container 10 and the media container is established. In one example, at least one of the sealed vials includes a medicament 22. In another example, the medicament 22 is reconstitutable (e.g., using the liquid 12 of the infusion container 10), and at least one of the vials 20 is under reduced pressure.

Reconstitution is typically accomplished by squeezing the infusion liquid bag 10 to push the infusion liquid 12 into the medium container 20, and then inverting the infusion liquid bag 10 to facilitate transfer of the vial contents. When one or both of the medium containers 20 includes a lyophilized medicament 22, the infusion liquid will reconstitute the medicament and may include several cycles of pushing the infusion liquid into the medium container 20 and expelling the vial contents into the IV bag 10.

Before or after the IV spike 322 is sealingly inserted into the IV port 16 (or 14), the cover 375 (user controlled) of one or both of the first vial adapter 101a or the second vial adapter 101b is manipulated into an unsealed configuration with the vent body cover, thereby providing venting of the system. After or during sufficient reconstitution, mixing or dilution of the medicament has occurred, the vent cover 375 is manipulated to an unsealed configuration, i.e., transitioned to the second state, thereby opening the vent to allow either vial 20 to be independently aspirated through the vent body 305 and optional vent filter 304 via the vent lumen 134a or 134b of the spike 200, respectively. In one example, only one vent cover 375 is opened. In another example, both vent covers 375 are open. Then, after removal of the twist-off closure member 144 (not shown), the infusion line spike 19 of the infusion set 18 is sealingly inserted into the transfer set infusion port 143 for delivery of the medication to the patient.

In one example, one or both media containers (e.g., vials 20) contain a medicament that is stored at a reduced atmospheric pressure. In one example, the reduced atmospheric pressure of the vial 20 forces a diluent of the infusion liquid bag 10 into the vial 20 for reconstituting, mixing or diluting the medicament contained therein.

Although not shown, the transfer devices 100, 100', 300, 400, 500a and 500b described so far all have an IV port 143, and such devices may be configured with an integrated infusion set, rather than connecting tubing directly to the IV port 143 at the IV port.

While the present disclosure has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the disclosure may be made within the scope of the appended claims.