Closed system transfer device protector with additional seal

Abstract

A system for transferring fluids, including a vial adapter having an adapter body with a first end and a second end opposite the first end, wherein the second end defines a cavity configured to at least partially receive a vial therein is disclosed. A fluid channel extends at least partially through the adapter body, the fluid passage having a proximal end and a distal end, the distal end positioned within the cavity, and a gasket may be attached to the distal end of the fluid channel.

Description

CLOSED SYSTEM TRANSFER DEVICE PROTECTOR WITH ADDITIONAL SEALCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 643,067 entitled “Closed System Transfer Device Protector with Additional Seal”, filed May 6, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to a system for the closed transfer of fluids. More particularly, the present disclosure relates to systems and devices that provide leak-proof sealing and pressure equalization during engagement with a vial.Description of Related Art

[0003] Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put them at risk of exposure to these medications and present a major hazard in the health care environment. For example, nurses treating cancer patients risk being exposed to chemotherapy drugs and their toxic effects. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. In order to reduce the risk of health care providers being exposed to toxic drugs, the closed transfer of these drugs becomes important.

[0004] Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial if any pressure differential between the interior of the vial and the surrounding atmosphere exists. Moreover, while existing vial adapters may be provided that conform to a standardized size or dimension of a vial, inconsistencies and variations in actual sizes and shapes of vials and stoppers therein may vary due to inconsistent or variable manufacturing, storage, or transporting processes. These inconsistencies or variations can result in ineffective sealing and compromised fluid transfer from such vials when coupled to an adapter.SUMMARY OF THE INVENTION

[0005] The present disclosure provides a vial adapter having an adapter body with a first end and a second end opposite the first end, wherein the second end defines a cavity configured to at least partially receive a vial therein. A fluid channel extends at least partially through the adapter body, the fluid passage having a proximal end and a distal end, the distal end positioned within the cavity, and a gasket may be attached to the distal end of the fluid channel.

[0006] In certain configurations, the adapter body is constructed from a first material, and the gasket is constructed from a second material different than the first material. In other configurations, the second material has a durometer less than a durometer of the first material. The gasket may be constructed from rubber, and the gasket may be attached to the distal end by an adhesive. Optionally, the gasket is welded to the distal end. In certain configurations, the gasket has a thickness between 0.5mm and 1.5mm.

[0007] In certain configurations, the vial adapter further comprises a pressure equalization device in fluid communication with the cavity.

[0008] In certain configurations, the adapter body defines a vent channel in fluid communication with the pressure equalization device. The vial adapter may further include a cannula attached to the vent channel, the cannula extending into the cavity. The gasket may surround at least a portion of the cannula.

[0009] In certain configurations, the vial adapter further includes a membrane adjacent the proximal end of the fluid channel. The first end of the adapter body may be configured to couple to a syringe.

[0010] In accordance with an embodiment of the present invention, a vial adapter includes an adapter body with a first region configured to receive a syringe, and a second region configured to at least partially receive a vial therein. A wall at least partially extending between the first and second regions, and a fluid passage extends through the wall, the fluid passage having a proximal end in the first regions and a distal end in the second region. The vial adapter further includes a gasket attached to the distal end of the fluid channel, a cannula in fluid communication with the second region, and a pressure equalization device in fluid communication with the cannula.

[0011] In certain configurations, the adapter body is constructed from a first material, and the gasket is constructed from a second material different than the first material. Optionally, the second material has a durometer less than a durometer of the first material. The gasket mayhave a thickness between 0.5mm and 1.5mm. In certain configurations, the gasket surrounds at least a portion of the cannula. Optionally, the vial adapter includes a membrane attached to the proximal end of the fluid channel.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more complete understanding of the present disclosure, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:

[0013] FIG. 1 is an exploded assembly view of an example of a vial adapter constructed in accordance with the principles of the present disclosure;

[0014] FIG. 2 is an underside perspective view of a portion of the vial adapter of FIG. 1 ;

[0015] FIG. 3 is a perspective view of an example of a connector of the vial adapter of FIG. 1;

[0016] FIG. 4 is a side cross-sectional view of the vial adapter of FIG. 1 in an example of a first configuration;

[0017] FIG. 5 is a side cross-sectional view of the vial adapter of FIG. 1 in an example of a second configuration;

[0018] FIG. 6 is a side view of the vial adapter of FIG. 1 in preparation for engagement to a vial;

[0019] FIG. 7 is a side view of the vial adapter coupled to the vial of FIG. 6; and

[0020] FIG. 8 is a partial side cross-sectional view of the vial adapter coupled to the vial of FIG. 6.DETAILED DESCRIPTION OF THE INVENTION

[0021] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0022] As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0023] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, relate to the embodiments or aspects as shown in the drawing figures and are not to be considered as limiting as the embodiments or aspects can assume various alternative orientations.

[0024] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. By “about” is meant within plus or minus twenty- five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0025] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0026] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0027] All documents referred to herein are “incorporated by reference” in their entirety.

[0028] The term “at least” is synonymous with “greater than or equal to.”

[0029] As used herein, “at least one of’ is synonymous with “one or more of.” For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0030] The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including.”

[0031] As used herein, the terms “parallel” or “substantially parallel” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1°, inclusive of the recited values.

[0032] As used herein, the terms “perpendicular”, “transverse”, “substantially perpendicular,” or “substantially transverse” mean a relative angle as between two objects at their real or theoretical intersection is from 85° to 90°, or from 87° to 90°, or from 88° to 90°,or from 89° to 90°, or from 89.5° to 90°, or from 89.75° to 90°, or from 89.9° to 90°, inclusive of the recited values.

[0033] The present disclosure provides devices, systems, and methods of use thereof that provide leak-proof sealing and pressure equalization during engagement with a vial or other container for subsequent fluid transfer. Referring now to the figures in which like reference designations refer to like elements, examples of a vial adapter 10 operable to securely attach to a vial for transfer of fluids are shown in FIGS. 1-5.

[0034] The vial adapter 10 may generally include or define an adapter body 12 with a first end or region 14 adapted or configured to engage or couple to a syringe, syringe adapter, or other instrument (not shown). The first end or region 14 may include or define a first cavity 15 sized and / or shaped to at least partially receive to a syringe, syringe adapter, or other instrument (not shown) therein. The adapter body 12 may define a second end or region 16 adapted or configured to at least partially receive or attach to a vial or other container. The second end or region 16 may include or define a second cavity 17 sized and / or shaped to at least partially receive or attach to a vial or other container. A connector 18 may be releasably attachable to the adapter body 12 on or about the second end 16, and may be configured or adapted to facilitate engagement between the adapter body 12 and a vial, as described herein. The vial adapter 10 may include a pressure equalization device 20 coupled to the adapter body 12. The pressure equalization device 20 may include a balloon-type or bellows-type pressure equalization arrangement, although any suitable pressure equalization arrangement may be utilized. The pressure equalization device 20 is configured to maintain the pressure within an attached vial during fluid transfer to prevent the vial from being pressurized or place in a vacuum. The vial adapter 10 may include a cannula 22 adapted or configured to pierce a stopper or seal of an attached vial. The cannula 22 may be in fluid communication with the pressure equalization device 20 as described herein.

[0035] Now referring to FIGS. 2 and 4-5, the adapter body 12 may include or define a fluid channel 24 at least partially extending from the first end or region 14 to the second end or region 16. The fluid channel 24 is configured or adapted to provide fluid communication and transfer between an attached vial coupled to the second end 16 of the adapter body 12 and a syringe or other instrument coupled to the first end 14 of the adapter body 12. The vial adapter 10 may include a membrane 26 at or adjacent to a proximal end of the fluid channel 24. The membrane 26 seals the fluid channel 24 until pierced by a syringe or other instrument for secure transfer of fluids as described further herein. The membrane 26 may include one or segmentsof fluid impermeable material, layers, coatings or otherwise to prevent or substantially reduce fluid flow through the proximal end of the fluid channel 26.

[0036] The adapter body 12 may include or define a vent channel 28 providing fluid communication between the cannula 22 and the pressure equalization device 20. The vent channel 28 may at least partially extend into the second end or region 16 of the adapter body 12, and a proximal end of the cannula 22 may extend from an opening or end of the vent channel 28.

[0037] The fluid channel 24 and / or vent channel 28 may be defined by one or more walls or segments of the adapter body 12. For example, the adapter body 12 may include or define a wall 30 at least partially extending between or separating the first region or end 14 from the second region or end 16 of the adapter body. The fluid channel 24 may extend through or define an opening in the wall 30, which may be located along an approximate midline of the adapter body 12 and / or substantially parallel to a longitudinal axis of the adapter body 12. The wall 30 may define or include an opening 32 in the second end or region 16 of the adapter body 12. The opening 32 may be defined at least in part by a flange or other annular segment of the wall 30 extending longitudinally into the second end 16 of the adapter body 12. The opening 32 may define or be in fluid communication with a distal end of the fluid channel 24, and may also extend to define or include at least a portion of the vent channel 28. In the illustrated example shown in FIG. 2, in which the cannula 22 is removed for ease of illustration, the opening 32 circumscribes a portion of the distal end of the fluid channel 24, and also encircles or surrounds the portion of the vent channel leading into the second end 16 of the adapter body 12.

[0038] The adapter 10 may include a gasket 34 coupled to the opening 32 to improve sealing or attachment of the adapter body 12 to a vial. The gasket 34 may have an annular or ring-like shape, and circumscribe or surround all or a portion of the distal end of the fluid channel 24. The gasket 34 may also or alternatively surround all or a portion of the vent channel 28 and / or the cannula 22. The gasket 34 may be constructed from a softer or more pliable material compared to a material constituting the adapter body 12. The gasket 34 may be sized and dimensioned to provide a pliable sealing interface with vial attached to the adapter 10, while minimizing resistance to coupling the adapter 10 to the vial or otherwise interfering with the fitment and relative positioning of the adapter 10 on or about the vial. In one example, the gasket 34 may have a thickness between approximately 0.5mm and 1.5mm, and preferably have a thickness of approximately 1.0mm. The gasket 34 may be attached to the adapter body12 through an adhesive, thermal boding, welding, ultrasonic welding, or other process assuring a sealing attachment between the gasket 34 and the adapter body 12.

[0039] In order to enable coupling between the adapter body 12 and the connector 18, the adapter body 12 may include first locking openings 36a arranged opposite each other in a peripheral or outer wall of the second end or region 16, and second locking openings 36b longitudinally spaced from the first locking openings 36a. The first and second locking openings 36a, 36b may constitute receiving members or female members of a snaplock arrangement allowing the adapter body 12 and the connector 18 to be releasably locked together. The adapter body 12 may include one or more guiding grooves 38 to facilitate alignment of the adapter body 12 and the connector 18. Alternative and / or additional coupling arrangements may be implemented to provide telescopic movement without simultaneous rotation between the adapter body 12 and the connector 18.

[0040] Now referring to FIGS. 3-5, the connector 18 may include two oppositely arranged flexible locking tongues 40 each carrying a locking protrusion 42 arranged to cooperate with the first locking openings 36a and the second locking openings 36b on the adapter body 12. The connector 18 may include opposing guiding elements 44 arranged to engage with the guiding grooves 38 on the adapter body 12. The connector 18 may include one or more retention elements 46 configured to securely attach or retain a neck portion of a vial. The retention elements 46 may include a flexible segment that can deflect when pushed onto a vial, then retract to an original position to hold the vial within the connector 18. The retention elements 46 may include on or more tabs, snaps, or other mechanical components that matably secure the connector 18 to a vial for fluid transfer.

[0041] The connector 18 may be positioned with the second end or region 16 of the adapter body 12 in a plurality of discrete, selectable positions. For example, now referring to FIG. 4, the vial adapter 10 is shown with the adapter body 12 coupled to the connector 18 in an initial transport or storage state, where the connector 18 is partially disposed within the second end or region 16 of the adapter body 12 such that the protrusions 42 engage the first locking openings 36a. In this configuration, the adapter 10 would be securely attached to a vial coupled to the connector 18, but the cannula 22 would not puncture or pierce a stopper or seal of an attached vial, thus preventing any leak or dispersion of the vial contents during transportation or storage.

[0042] Now referring to FIG. 5, the vial adapter 10 is shown with the adapter body 12 coupled to the connector 18 in a fluid transfer state, where the connector 18 is disposed furtheraxially within the second end or region 16 of the adapter body 12 compared to the initial stage shown in FIG. 4, such that the protrusions 42 engage the second locking openings 36b. In this configuration, the cannula 22 would puncture or pierce a stopper or seal of an attached vial, placing the contents of the vial in fluid communication with the pressure equalization device 20. In addition, the gasket 34 would abut a stopper or seal on an upper surface of the vial, which could then be accessed by a syringe through the membrane 26 and the fluid channel 24.

[0043] In an alternative configuration, one or more features of the connector 18 may be directly incorporated into or otherwise integral with the second end or region 16 of the adapter body 12. For example, the one or more retention elements 46 configured to securely attach or retain a neck portion of a vial may extend directly from a sidewall or other segment of the second end 16 to directly attach the adapter body 12 to a vial. The one or more retention elements 46 configured directly on the adapter body 12 may provide for a single state or position of an attached vial relative to the adapter body 12, cannula 22, pressure equalization device 20, and / or fluid channel 24, where the adapter body 12 is only attached to a vial for immediate fluid transfer rather than for storage or transportation.

[0044] Now referring to FIG. 6, the adapter 10 may be positioned in preparation to engage a vial or container 48. The vial 48 may include a bottle neck 50 and a sealing member 52 inserted into or otherwise positioned about an opening of the vial 48. The sealing member 52 may include, for example, a stopper which may be penetrated by the cannula 22 and by an external piercing member such as a syringe. In the configuration shown in FIG. 5, the connector 18 is in the first, initial position with respect to the adapter body 12 as described above and illustrated in FIG. 4.

[0045] Now referring to FIG. 7, the connector 18 is secured to the vial 48, for example, by way of the one or more retention elements 46 engaging the neck 50 of the vial 48. The adapter body 12 may be pushed down or otherwise actuated to transition the connector 18 to the second, fluid transfer position, as described herein and shown in FIG. 5. In this configuration, as shown in the cross-sectional view of FIG. 8, the gasket 34 forms a leak proof seal with the sealing member 52 of the vial. The cannula 22 pierces the sealing member 52 to provide fluid communication between an interior of the vial 48 and the pressure equalization device 20. A syringe may be used to pierce the membrane 26, traverse the fluid channel 24, and transfer fluids with the interior of the vial 48.

[0046] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unlessmention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.

Claims

WHAT IS CLAIMED IS:

1. A vial adapter, comprising: an adapter body with a first end and a second end opposite the first end, wherein the second end defines a cavity configured to at least partially receive a vial therein; a fluid channel extending at least partially through the adapter body, the fluid passage having a proximal end and a distal end, the distal end positioned within the cavity; and a gasket attached to the distal end of the fluid channel.

2. The vial adapter of claim 1, wherein the adapter body is constructed from a first material, and the gasket is constructed from a second material different than the first material.

3. The vial adapter of claim 2, wherein the second material has a durometer less than a durometer of the first material.

4. The vial adapter of claim 1, wherein the gasket is constructed from rubber.

5. The vial adapter of claim 1, wherein the gasket is attached to the distal end by an adhesive.

6. The vial adapter of claim 1, wherein the gasket is welded to the distal end.

7. The vial adapter of claim 1, wherein the gasket has a thickness between 0.5mm and 1.5mm.

8. The vial adapter of claim 1, further comprising a pressure equalization device in fluid communication with the cavity.

9. The vial adapter of claim 8, wherein the adapter body defines a vent channel in fluid communication with the pressure equalization device.

10. The vial adapter of claim 9, further comprising a cannula attached to the vent channel, the cannula extending into the cavity.

11. The vial adapter of claim 10, wherein the gasket surrounds at least a portion of the cannula.

12. The vial adapter of claim 1, further comprising a membrane adjacent the proximal end of the fluid channel.

13. The vial adapter of claim 12, wherein the first end of the adapter body is configured to couple to a syringe.

14. A vial adapter, comprising: an adapter body with a first region configured to receive a syringe, and a second region configured to at least partially receive a vial therein; a wall at least partially extending between the first and second regions; a fluid passage extending through the wall, the fluid passage having a proximal end in the first regions and a distal end in the second region; a gasket attached to the distal end of the fluid channel; a cannula in fluid communication with the second region; and a pressure equalization device in fluid communication with the cannula.

15. The vial adapter of claim 14, wherein the adapter body is constructed from a first material, and the gasket is constructed from a second material different than the first material.

16. The vial adapter of claim 15, wherein the second material has a durometer less than a durometer of the first material.

17. The vial adapter of claim 14, wherein the gasket has a thickness between 0.5mm and 1.5mm.

18. The vial adapter of claim 14, wherein the gasket surrounds at least a portion of the cannula.

19. The vial adapter of claim 14, further comprising a membrane attached to the proximal end of the fluid channel.

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