Universal adapter for closed system drug transfer device

Abstract

A vial adapter for accessing a vial is provided herein. The vial adapter includes a base having a distal side and a proximal side with a base lumen extending between the distal side and the proximal side. The vial adapter further includes: a first connector positioned at a distal side of the base and configured to couple with a vial; a second connector positioned on a proximal side of the base and configured to couple with a fluid container; and a lancet element extending distally from the base and configured to pierce a stopper of a vial, the lancet element defining a lancet lumen in fluid communication with the base lumen. The first connector is positioned on the lancet element and includes an arm structure configured to engage with the stopper to secure the vial adapter to the vial.

Description

Cross Reference to Related Applications

[0001] This application claims priority to Indian Provisional Application No. 202311036757, filed May 27, 2023, entitled “Universal Adapter for Closed-System Drug Transfer Device,” the disclosure of which is hereby incorporated by reference in its entirety.

[0002] Background of the Invention Field of the Invention The present disclosure relates generally to closed-system drug transfer devices, and more particularly, to a universal adapter for a closed-system drug transfer device that can be coupled to various sizes of vials.

[0003] Description of the Related Art Healthcare providers, medical device and pharmaceutical manufacturers, and major government and regulatory agencies have long recognized the problems faced by healthcare workers when compounding and administering hazardous drugs. For example, nurses caring for cancer patients are at risk of exposure to these drugs when compounding and administering chemotherapy drugs, and such inadvertent chemotherapy exposure can affect the nervous system, impair the reproductive system, and / or increase the risk of developing blood cancer in the future.

[0004] To reduce the risk of healthcare workers being exposed to hazardous drugs, closed transfer of these drugs has become very important, and various policies and regulations have been implemented requiring the use of closed-system drug transfer devices (CSTDs) when compounding and administering hazardous drugs. A CSTD connects to a vial containing a hazardous drug via an adapter or vial access device—where the CSTD provides for the safe withdrawal of the hazardous drug from the vial and subsequent drug compounding or administration. A CSTD can utilize a physical barrier that inhibits the escape of hazardous drug substances, thereby reducing the risk of exposure to healthcare workers who can be compounding or administering the hazardous drug to a patient.

[0005] As noted above, adapters or access devices are commonly used to couple CSTDs to vials. One drawback of existing adapters is that they are not suitable for use with different types and / or sizes of vials. That is, vials that provide hazardous drugs (e.g., chemotherapy drugs) can vary in size depending on the type and recommended dosage of the drug being administered, and the size of the vial head (which has an opening therein) will also vary accordingly. Existing CSTD adapters are typically designed to mate with vial heads having a specific size, which means that various configurations of CSTD adapters must be available at a healthcare facility in order to accommodate vials of different sizes. The need for multiple adapter configurations can unnecessarily complicate workflow and increase costs at healthcare facilities.

[0006] Accordingly, there is a need in the art for a universal CSTD adapter that can be connected to hazardous vials having a variety of sizes and configurations. SUMMARY

[0007] A vial adapter for accessing a vial is provided herein. The vial adapter includes a base having a distal side and a proximal side, with a base lumen extending between the distal side and the proximal side. The vial adapter further includes a first connector positioned distally of the base and configured to couple with the vial, a second connector positioned proximally of the base and configured to couple with a fluid container, and a spike element extending distally from the base and configured to pierce a stopper of the vial, the spike element defining a spike lumen in fluid communication with the base lumen. The first connector is positioned over the spike element, and the first connector includes an arm structure configured to engage the stopper to secure the vial adapter to the vial.

[0008] In some embodiments, the first connector includes a sleeve element positioned around the spike element, proximate a proximal end of the spike element so as to abut the base, the sleeve element including a plurality of slots formed therein. The first connector further includes a plurality of pre-loaded arms forming the arm structure, the plurality of pre-loaded arms positioned within the sleeve element and biased radially outward away from the spike element and toward the sleeve element. The plurality of pre-loaded arms are rotatable relative to the sleeve such that an end of each of the plurality of pre-loaded arms can be brought into alignment with and pushed out of a respective slot of the plurality of slots such that a portion of each of the plurality of pre-loaded arms is positioned outside of the sleeve element.

[0009] In some embodiments, the sleeve element is held by the stopper when the spike element is inserted into the stopper to prevent rotation of the sleeve element relative to the stopper, and wherein subsequent rotation of the vial adapter causes the plurality of pre-loaded arms to be pushed out through the plurality of slots.

[0010] In some embodiments, an adhesive is applied to an outer surface of the sleeve element, the adhesive configured to adhere the sleeve element to the stopper.

[0011] In some embodiments, the first connector includes an arm guide positioned about the lancet element and axially translatable along the lancet element, and a plurality of expandable arms forming an arm structure, the plurality of expandable arms configured to deflect radially inwardly and outwardly relative to the lancet element. Each expandable arm of the plurality of expandable arms further includes a distal end connected to the lancet element, and a proximal end movable within the arm guide.

[0012] In some embodiments, when the lancet element is inserted into the stopper, the arm guide is caused to translate proximally along the lancet element such that the proximal end of each expandable arm of the plurality of expandable arms moves out of the arm guide, the plurality of expandable arms engages the stopper, and exerts a radially outward pressure on the stopper.

[0013] In some embodiments, the arm structure of the first connector includes one or more cantilevered retention arms, each of the one or more cantilevered retention arms connected to the lancet element proximate a distal end of the lancet element and angled radially outwardly away from the lancet element. Each of the one or more cantilevered retention arms is configured to deflect radially inwardly toward the lancet element.

[0014] In some embodiments, insertion of the lancet element into the stopper causes the one or more cantilevered retention arms to contact the stopper and deflect radially inwardly. When the lancet element is fully pushed through the stopper, the one or more cantilevered retention arms are positioned distal to the stopper and move radially outwardly back to a default position, the one or more cantilevered retention arms engaging a back surface of the stopper.

[0015] In some embodiments, the second connector includes a connector lumen extending through the second connector and in fluid communication with the base lumen and the lancet lumen.

[0016] In some embodiments, the lancet element includes a vent lumen formed therein, and wherein the vial adapter further includes a pressure equalization element coupled to the base and in fluid communication with the vent lumen.

[0017] Also provided herein is another vial adapter for accessing a vial. The vial adapter includes a base having a distal side and a proximal side, with a base lumen extending between the distal side and the proximal side. The vial adapter also includes a first connector positioned distally of the base and configured to couple with a stopper, a second connector positioned proximally of the base and configured to couple with a fluid container, and a spike element extending distally from the base and configured to pierce the stopper of the vial, the spike element defining a spike lumen in fluid communication with the base lumen. The first connector includes a plurality of gripping arms extending distally and radially outward from the distal side of the base, each gripping arm of the plurality of gripping arms having a first end connected or engaged with the base and a second end opposite the first end, and an actuation element actuatable by a user to move the second end of each gripping arm of the plurality of gripping arms radially inward to bring the plurality of gripping arms into contact with the vial to secure the vial adapter to the vial.

[0018] In some embodiments, each gripping arm of the plurality of gripping arms includes a flexible side arm configured to deflect radially inward.

[0019] In some embodiments, the actuation element includes a zip tie looped through an engagement feature formed on each side wall of the plurality of side arms, and wherein tensioning of the zip tie causes the second end of each side wall of the plurality of side arms to deflect radially inward and into contact with the vial.

[0020] In some embodiments, the engagement feature includes one of: a hook or channel formed proximate the second end of the side arm that secures the zip tie to the side arm; or one or more holes formed in the side arm through which a respective hole of the zip tie is passed to secure the zip tie to the side arm.

[0021] In some embodiments, the actuation element is an elastic ring engaged with each side arm of the plurality of side arms at the second end of the side arm, and wherein the elastic ring exerts a contraction force that causes the second end of each side arm of the plurality of side arms to deflect radially inward and into contact with the vial.

[0022] In some embodiments, the first connector is a track system, the plurality of gripping arms includes a plurality of click arms each including a pair of slotted tracks formed on a first end of the click arm, and the actuation element includes a tooth element disposed on a track housing positioned proximally of the base, the tooth element and the slotted tracks interacting to move the plurality of click arms radially inward.

[0023] In some embodiments, each of the plurality of snap arms includes a generally C-shaped element with a first end oriented parallel to an upper surface of the vial and having a slotted track formed on the first end, and a second end oriented parallel to the first end.

[0024] In some embodiments, a distance between the first end and the second end receives positioning of a head portion of the vial within a channel defined by the C-shaped gripping arm.

[0025] In some embodiments, the plurality of snap arms are movable radially inward relative to the base, and wherein engagement of the tooth element with the slotted track locks the plurality of snap arms in place when the plurality of snap arms are movable radially inward and in contact with the vial.

[0026] In some embodiments, the spike element includes a vent lumen formed therein, and wherein the vial adapter further includes a pressure equalization element coupled to the base and in fluid communication with the vent lumen.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of a closed system drug transfer device (CSTD) with which embodiments of the present disclosure can be implemented; Figure 2 is a perspective view of a vial adapter according to an embodiment of the present disclosure; Figure 3 is a perspective view of the vial adapter of Figure 2 shown coupled to a vial; Figure 4 is a cross-sectional view of the vial adapter of Figure 3 and a vial; Figure 5A is a detailed perspective view of a first connector included in the vial adapter of Figure 2 in an unactuated state; Figure 5B is a bottom view of the first connector of Figure 5A ; Figure 6A is a detailed perspective view of a first connector included in the vial adapter of Figure 2 in an actuated state; Figure 6B is a bottom view of the first connector of Figure 6A ; Figure 7 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 8 is a cross-sectional view of the vial adapter of Figure 7 shown coupled to a vial; Figure 9 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 10 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 9 is a cross-sectional view of the vial adapter of Figure 11 is a front perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 12 is a bottom perspective view of the vial adapter of Figure 11 Figure 13 is a perspective view of a vial adapter according to another embodiment of the present disclosure, shown coupled to a vial; Figure 11 is a cross-sectional view of the vial adapter and vial of Figure 14 Figure 13 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 15 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 16 is a perspective view of a vial adapter according to another embodiment of the present disclosure; Figure 17 is a perspective view of a vial adapter according to another embodiment of the present disclosure, shown coupled to a vial; Figure 17A is a detailed perspective view of a portion of the vial adapter of Figure 17 Figure 18 is a cross-sectional view of the vial adapter and vial of Figure 17 Figure 19 is a cross-sectional view of the vial adapter of Figure 17

[0028] DETAILED DESCRIPTION The following description is provided so as to enable any person skilled in the art to make and use the described embodiments of the application for which patent protection is sought. Various modifications, equivalents, variations, and alternatives, however, will remain 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 application.

[0029] ​​​​​In the following description, for the purposes of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and derivatives thereof shall relate to the application as oriented in the drawing figures. However, it is to be understood that the application can assume various alternative orientations and, accordingly, such specific embodiments are not to be considered in a limiting sense as described herein. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless otherwise indicated.

[0030] As used in this specification, the words "proximal" and "distal" refer to directions closer to and farther from, respectively, such a user who is to place the device in contact with another component or with a patient. Thus, for example, the end of the device that is to contact the other component or the patient's body first would be the distal end, while the opposite end, which is to be manipulated by the user, would be the proximal end of the device.

[0031] The terms "first" and "second" and the like, do not denote any particular order or chronology, but rather, refer to different conditions, properties, or elements.

[0032] Reference Figure 1 is shown, a non-limiting embodiment of a system 10 for closed transfer of fluids, i.e., a closed system drug transfer device (CSTD) 10, with which aspects of the present disclosure can be implemented. The CSTD 10 includes a syringe adapter 12 and a vial access device or vial adapter 14. The CSTD 10 provides a substantially leak-proof seal during: the engagement of a cannula (shown in dashed lines at 15) of the syringe adapter 12 with a vial 16; the transfer of a substance from the vial 16 to the syringe adapter 12 (and a syringe 18 connected thereto) through the cannula 15; and the disengagement of the cannula 15 from the vial 16. The leak-proof seal of the CSTD 10 substantially prevents the leakage of air and liquid during use of the CSTD 10. The CSTD 10 is compatible with a syringe 18 that is used to access a drug contained within the vial 16 for administration of the drug to a patient. The CSTD 10 can also be used compatibly with an intravenous (IV) bag, an IV line, a patient connector, or other aspects to move fluid from a vial to another device or component.

[0033] According to aspects of the present disclosure, described herein are vial adapters 14 that can be included in a CSTD 10, where the vial adapters 14 are configured as a universal adapter that accommodates different types and / or sizes of vials 16. The vial adapters 14 are adapted for use with syringe adapters 12 included in commercially available existing CSTDs 10, such as the syringe adapters included in the PhaSeal™ system from Becton, Dickinson and Company. As will be described in detail below, the vial adapters 14 can include an internal locking or coupling mechanism, or an external locking or coupling mechanism, that allows the vial adapters 14 to be secured to a range of vial sizes.

[0034] Reference is now made to Figure 2 Turning to FIG. 6, a vial adapter 14a according to embodiments of the present disclosure is shown. The vial adapter 14a includes a base 20, a spike element 22, and a pressure equalization chamber 24. In some embodiments, the base 20, the spike element 22, and the pressure equalization chamber 24 are formed as a single unitary component, and can be formed from a polymeric material (e.g., injection molded polypropylene), although other suitable materials can be used. In other embodiments, the spike element 22 and the pressure equalization element 24 can be connected to the base 20 by a suitable connection.

[0035] The base 20 can be configured as a generally circular or cylindrical component that has a circumference that is slightly larger than the circumference of the head portion 26 of the vial 16. The base 20 includes a distal side 28 that faces the vial 16 to which the vial adapter 14a is to be connected, and a proximal side 30 that faces the syringe adapter 12 to which the vial adapter 14a is to be connected. In some embodiments, each of the distal side 28 and the proximal side 30 of the base 20 are configured to have a generally flat structure, with the flat structure of the distal side 28 enabling flush contact when the vial adapter 14a is secured to the vial 16. Within the base 20, a fluid lumen 32 is defined that allows fluid to be transferred from the vial 16, as will be explained in further detail below.

[0036] The base 20 is provided with a first connector 34a and a second connector 36, which can be integrally formed with the base 20 or connected to the base 20, according to embodiments. The first connector 34a is provided on the distal side 28 of the base 20, and the second connector 36 is provided on the proximal side 30 of the base 20. The first connector 34a is configured to be secured to the vial 16, as shown and described previously in Figure 1 The second connector 36 is configured to be secured to the syringe adapter 12 (and further in fluid communication with the syringe 18 or other fluid container), as shown and described previously in Figure 1shown and described.

[0037] The second connector 36 includes a central shaft 38 that is integrally formed with the base 20 and extends proximally from the base 20. A lumen 40 is formed within the central shaft 38, extending between a distal end 42 and a proximal end 44 of the second connector 36, where the lumen 40 is fluidly connected to the lumen 32 in the base 20. The lumen 40 terminates at a proximal opening 46 disposed at the proximal end 44 of the central shaft 38, and a seal (not shown) can be disposed over the proximal opening 42 that can be pierced by the cannula 15 of the syringe adapter 12 when the syringe adapter 12 is connected to the lumen 40. Figure 1 A port 48 is disposed at the proximal end 44 of the central shaft 38 that provides access to the lumen 40 when the syringe adapter 12 is connected to the lumen 40. The central shaft 38 can include a flange 50 and an arrangement of snap-fit fingers 52 that protrude radially outward therefrom, and the snap-fit fingers 52 cooperate with the syringe adapter 12 when the syringe adapter 12 is slid linearly down onto the second connector 36. That is, although not shown in Figures 2-4 , it is recognized that the flange 50 and snap-fit fingers 52 will engage with a guide slot formed on an inner surface of the syringe adapter 12, where the snap-fit fingers 52 flex and form a snap-fit engagement with the slot to secure the syringe adapter 12 to the vial adapter 14a.

[0038] The needle element 22 extends distally away from the distal end 28 of the base 20, and the needle element 22 includes a proximal end 54 and a distal end 56. The needle element 12 defines a vent lumen 58 and a fluid lumen 60 that extend the length of the needle element 22, where the fluid lumen 60 is in fluid communication with the lumen 32 in the base 20 and the lumen 40 in the second connector 36. As Figure 3 and Figure 4 shown, the needle element 22 includes a sharp tip 62 at its distal end 56 that is configured to pierce a stopper 64 (or another sealing element) on the vial 16 during connection of the vial adapter 14 to the vial 16. The vent lumen 58 and the fluid lumen 60 each include proximal and distal openings. Although not shown, it is recognized that the fluid lumen 60 is configured to receive a cannula from the syringe adapter 12 that extends through the base 20 of the vial adapter 14a (i.e., through the lumen 32 of the base 20) to allow fluid to be transferred between the vial 16 and a fluid container (e.g., the syringe 18) coupled to the syringe adapter 12 through the cannula. The fluid lumen 60 extends longitudinally (axially) along the needle element 22 between the proximal end 54 and the distal end 56 thereof.

[0039] The pressure equalization chamber 24 is disposed on the base 20 and extends radially outward therefrom. The pressure equalization chamber 24 has a generally parabolic shape and is in fluid communication with the lumen 32 in the base 20 through a pressure chamber passage 66Figure 4 The pressure chamber passage 66 is in fluid communication with the vent lumen 58 of the spike element 22 and extends partially into the base 20 and generally perpendicular to the vent lumen 58. The pressure chamber passage 66 has an opening 68 that is located substantially in the center of the chamber 24. Although not shown in Figures 2-4 it is recognized that the pressure balancing chamber 24 has an inflatable bladder disposed thereon that encloses a volume in the chamber that is movable between an uninflated state and an inflated state to maintain a predetermined pressure within the vial 16 during the flow of fluid from the vial.

[0040] As noted above, the first connector 34a is disposed on the distal side 28 of the base 20 and is configured to connect the vial adapter 14a to the vial 16. In Figure 2 to the embodiment shown in FIG. 6, the first connector 34a is configured to engage an internal locking or coupling mechanism of the stopper 64 of the vial 16. As Figure 5A and Figure 5B and Figure 6A and Figure 6B As best shown in FIGS. 5 and 6, the first connector 34a includes a sleeve element 72 and a plurality of pre-loaded arms 74 (forming an arm structure). The sleeve element 72 is positioned around the spike element 22, proximate the proximal end 54 of the spike element 22, such that the sleeve element 72 abuts the distal side 28 of the base 20. In some embodiments, the sleeve element 72 can be fixed to the base 20. The pre-loaded arms 74 are positioned within the sleeve element 72. The number of pre-loaded arms 74 disposed within the sleeve 72 can vary according to the embodiment, but is at least two arms, with three arms shown in the illustrated embodiment. The pre-loaded arms 74 are configured as resilient, tab-like arms that are biased radially outward away from the spike element 22 and toward the sleeve element 72, e.g., the arms 74 are formed of polypropylene, polyethylene, or spring steel. In operation of the first connector 34a, the pre-loaded arms 74 can be selectively driven or moved from within the sleeve element 72 to outside of the sleeve element 72. The sleeve element 72 includes a plurality of slots 76 formed therein, with the number of slots 76 matching the number of pre-loaded arms 74 (e.g., three slots 76 / arms 74). The plurality of pre-loaded arms 74 are rotatable relative to the sleeve element 72 such that an end of each of the plurality of pre-loaded arms 74 can be selectively aligned with a respective slot 76 and actuated outwardly through the slot 76 such that a portion of each of the plurality of pre-loaded arms 74 can be actuated from an interior of the sleeve element 72 to an exterior of the sleeve element 72.

[0041] To couple the vial adapter 14a to the vial 16 via the first connector 34a, the vial adapter 14a and the vial 16 are initially aligned and pushed toward one another such that the spike element 22 is driven into and through the stopper 64 of the vial 16. Driving the spike element 22 into the stopper 64 causes the sleeve element 72 positioned on the spike element 22 to also be driven into the stopper 64. With at least a portion of the sleeve element 72 positioned within the stopper 64, the sleeve element 72 is held in a fixed position relative to the stopper 64. In some embodiments, and to further ensure that the sleeve element 72 is held relative to the stopper 64, an adhesive (e.g., an adhesive film) can be applied to at least a portion of the outer surface of the sleeve element 72.

[0042] When the sleeve element 72 is positioned within the stopper 64, the vial adapter 14a and the vial 16 can be rotated relative to one another in order to push the pre-load arm 74 out of the sleeve element 72. Depending on the embodiment, a user can grasp the vial adapter 14a to rotate the adapter relative to the vial 16, or can grasp the vial 16 to rotate the vial 16 relative to the vial adapter 14a. Rotation of the vial adapter 14a and the vial 16 relative to one another causes the end of the pre-load arm 74 to align with the slot 76 formed in the sleeve element 72 and to be pushed out through the slot 76. Additional rotation of the vial adapter 14a relative to the vial 16 causes the pre-load arm 74 to further extend out of the sleeve element 72. In embodiments in which the sleeve element 72 and the pre-load arm 74 are aligned with the stopper 64 in a vertical direction (after the spike element 22 is inserted through the stopper 64), additional rotation of the vial adapter 14a relative to the vial 16 causes the pre-load arm 74 to be inserted into the resilient material of the stopper 64. In embodiments in which the sleeve element 72 and the pre-load arm 74 are distanced from the stopper 64 (after the spike element 22 is inserted through the stopper 64), additional rotation of the vial adapter 14a relative to the vial 16 causes the pre-load arm 74 to extend out of the sleeve element 72, where the sleeve element 72 and the pre-load arm 74 can come into contact with the back surface 78 of the stopper 64. Thus, the pre-load arm 74 provides a plurality of connection points between the first connector 34a and the vial 16 that serve to prevent a loose or wobbly connection between the first connector 34a and the vial 16, thereby securely holding the vial adapter 14a on the vial 16.

[0043] With the first connector 34a coupled to the vial 16 in this manner, vials of any size can be connected to the vial adapter 14a. That is, with the first connector 34a connected to the stopper 64 via the pre-load arm 74 coupling to the interior of the stopper 64 of the vial 16, the size of the open head portion 26 of the vial 16 can vary without affecting the securement of the vial adapter 14a to the vial 16.

[0044] Referring now to Figure 7and Figure 8 A vial adapter 14b according to another aspect of the present disclosure is shown. The vial adapter 14b is substantially similar to the vial adapter 14a shown in FIGS. 1-6 (i.e., the base 20, the spike element 22, the pressure equalization chamber 24, the second connector 36 are the same), so like elements are labeled the same in the vial adapter 14b. As described in detail below, the structure of the first connector 34b provided in the vial adapter 14b is different than the first connector 34a of FIGS. 1-6, and provides another means for locking / coupling the interior of the vial adapter 14b to the vial 16. Figure 2 Figure 2 The first connector 34b is configured as an internal locking or coupling mechanism that is configured to engage the stopper 64 of the vial 16, as shown in FIGS. 7-9. The first connector 34b includes an arm guide 80 and a plurality of expandable arms 82 (forming an arm structure). According to embodiments, the number of expandable arms 82 provided can vary, but is at least two arms, as shown in the illustrated embodiment. The arm guide 80 is positioned about the spike element 22 and is movable relative to the spike element 22, sliding axially along the spike element 22 as the spike element 22 is forced into the stopper 64. Each of the plurality of expandable arms 82 has a distal end 84 that is connected to the spike element 22 (e.g., molded integrally with the spike element 22) proximate the distal end of the spike element 22. A proximal end 86 of each expandable arm 82 is initially housed within the arm guide 80, for example by being aligned and retained within a channel of the arm guide 80. As the arm guide 80 translates axially along the spike element 22 (i.e., proximally along the spike element 22), the proximal end 86 of each expandable arm 82 is released from the arm guide 80. As each of the plurality of expandable arms 82 is biased to expand radially outward relative to the spike element 22, the expandable arms 82 deflect / expand radially outward as the expandable arms 82 are released from the arm guide 80.

[0045] As shown in FIGS. 7-9, the first connector 34b is configured as an internal locking or coupling mechanism that is configured to engage the stopper 64 of the vial 16. The first connector 34b includes an arm guide 80 and a plurality of expandable arms 82 (forming an arm structure). According to embodiments, the number of expandable arms 82 provided can vary, but is at least two arms, as shown in the illustrated embodiment. The arm guide 80 is positioned about the spike element 22 and is movable relative to the spike element 22, sliding axially along the spike element 22 as the spike element 22 is forced into the stopper 64. Each of the plurality of expandable arms 82 has a distal end 84 that is connected to the spike element 22 (e.g., molded integrally with the spike element 22) proximate the distal end of the spike element 22. A proximal end 86 of each expandable arm 82 is initially housed within the arm guide 80, for example by being aligned and retained within a channel of the arm guide 80. As the arm guide 80 translates axially along the spike element 22 (i.e., proximally along the spike element 22), the proximal end 86 of each expandable arm 82 is released from the arm guide 80. As each of the plurality of expandable arms 82 is biased to expand radially outward relative to the spike element 22, the expandable arms 82 deflect / expand radially outward as the expandable arms 82 are released from the arm guide 80. Figure 7 Figure 8

[0046] ​​​To couple the vial adapter 14b to the vial 16 via the first connector 34b, the vial adapter 14b and the vial 16 are initially aligned and pushed toward each other, causing the needle element 22 to be driven into and through the stopper 64 of the vial 16. Driving the needle element 22 into the stopper 64 causes the arm guide 80 positioned on the needle element 22 to be pushed proximally back along the needle element 22. As the arm guide 80 is translated proximally back along the needle element 22, and the needle element 22 continues to be driven into the stopper 64, the extendable arm 82 is also driven into the stopper 64 and released from the arm guide 80. After the needle element 22 is inserted through the stopper 64, at least a portion of the extendable arm 82 (i.e., the distal end 84 of the extendable arm 82) can be located distal to the rear surface 78 of the stopper 64. As the extendable arm 82 is released from the arm guide 80 and at least a portion thereof is pushed through the stopper 64, the extendable arm 82 thus extends radially outward, thereby applying radially outward pressure to the stopper 64 and / or contacting the rear surface 78 of the stopper 64. Therefore, the extendable arm 82 provides multiple connection points between the first connector 34b and the vial 16, thereby securely holding the vial adapter 14b to the vial 16.

[0047] According to another aspect of this disclosure, in Figure 9 and Figure 10 The image shows a medicine bottle adapter 14c. The medicine bottle adapter 14c is basically similar to... Figure 2 Up to Figure 6 and Figures 7-8 The vial adapters 14a and 14b shown (i.e., base 20, needle element 22, pressure equalization chamber 24, and second connector 36 are identical) therefore, the same components in vial adapter 14c are labeled identically. As detailed below, the structure of the first connector 34c disposed in vial adapter 14c differs from that shown in the previous description. Figure 2 Up to Figure 6 and Figures 7-8 The first connectors 34a and 34b are provided, and another means is provided for locking / coupling the internal components of the vial adapter 14c to the vial 16.

[0048] like Figure 9 and Figure 10 As shown, the first connector 34c includes one or more cantilever retaining arms 90 (forming an arm structure). According to embodiments, the number of cantilever retaining arms 90 provided can vary—two arms are shown in the illustrated embodiment, but it should be understood that more arms can be provided, or conversely, only a single conical "arm" can be provided. Figure 9 and Figure 10As shown, the distal end 92 of each cantilevered retention arm 90 is connected to the lancet element 22 near the distal end 56 of the lancet element 22 (e.g., molded integrally with the lancet element 22). When the cantilevered retention arms 90 are in their default position, the cantilevered retention arms 90 are tilted radially outward away from the lancet element 22 such that the proximal end 94 of each cantilevered retention arm 90 is spaced apart from the lancet element 22. Each of the plurality of cantilevered retention arms 90 is configured as a flexible element that deflects radially inward toward the lancet element 22 when pressure is applied thereto.

[0049] To couple the vial adapter 14c to the vial 16 via the first connector 34c, the vial adapter 14c and the vial 16 are initially aligned and pushed toward one another such that the lancet element 22 is driven into and through the stopper 64 of the vial 16. Driving the lancet element 22 into the stopper 64 brings the cantilevered retention arms 90 into contact with the stopper 64 and also causes the arms 90 to be driven into the stopper 64. As the cantilevered retention arms 90 are driven into the stopper 64, the arms 90 deflect radially inward, for example, by an amount such that the arms 90 lie flat against the lancet element 22. As shown, Figure 10 When the lancet element 22 is fully pushed through the stopper 64, the cantilevered retention arms 90 are positioned distal to the stopper 64 and are allowed to deflect / move radially outward back to their default position, where the cantilevered retention arms 90 engage the back surface 78 of the stopper 64. Thus, the cantilevered retention arms 90 provide a plurality of connection points between the first connector 34c and the vial 16, thereby securely retaining the vial adapter 14c to the vial 16.

[0050] Referring now to Figures 11-15 , a vial adapter 14d according to additional aspects of the present disclosure is shown. The vial adapter 14d is substantially similar to the vial adapters 14a, 14b, 14c shown in FIGS. 1-6, Figure 2 through FIG. 6, Figures 7-8 and Figures 9-10 (i.e., the base 20, the lancet element 22, the pressure equalization chamber 24, the second connector 36 are the same), thus like elements are labeled the same in the vial adapter 14d. As provided in detail below, the structure of the first connector 34d provided in the vial adapter 14d is different from the first connectors 34a, 34b, 34c in FIGS. 1-6, Figure 2 through FIG. 6, Figures 7-8 and Figures 9-10 because the first connector 34d is configured as an external locking or coupling mechanism that is configured to engage or grasp the head portion 26 of the vial 16.

[0051] As Figures 11-15As shown, the first connector 34d includes a plurality of gripping arms 96 and associated actuation elements 98 for moving the gripping arms 96 and bringing them into contact with the vial 16. The gripping arms 96 are integrally formed with the base 20 (i.e., a first (or proximal) end 100 of each of the plurality of side arms 96 is connected to the base 20) and extend distally and radially outward from the distal side 28 of the base 20 - thus the gripping arms 96 are hereinafter referred to as "side arms 96." According to an embodiment, the number of side arms 96 provided on the vial adapter 14d can vary, but is at least three arms, with four arms shown in the illustrated embodiment. The side arms 96 are positioned equidistantly around the perimeter of the base 20. The side arms 96 are configured as flexible side arms 96 that are capable of deflecting radially inward from an initial or default position when an inward force is applied to the flexible side arms 96, as will be explained further below.

[0052] According to an embodiment, the actuation elements 98 are provided in the form of a zipper strip (hereinafter referred to as "zipper strip 98") that is actuable by a user (i.e., a healthcare worker) to move a second (or distal) end 102 of each of the plurality of flexible side arms 96 radially inward, thereby bringing the plurality of side arms 96 into contact with the vial 16 to secure the vial adapter 14d to the vial 16. The zipper strip 98 is threaded through an engagement feature 104 formed on each of the plurality of flexible side arms 96, thereby securing the zipper strip 98 to the flexible side arms 96. In one embodiment, as shown in FIGS. 3 and 4, the engagement feature 104 is provided as a hook or channel feature formed adjacent the second end 102 of the side arm 96 on an inner surface of the side arm 96. In another embodiment, as shown in FIGS. 5 and 6, the engagement feature 104 is provided as one or more holes formed in each of the plurality of side arms 96 (e.g., adjacent the second end 102 of the side arm 96 and / or near a middle portion of the side arm 96), with the zipper strip 98 selectively threaded through a desired hole to secure the zipper strip 98 to the side arm 96. Figures 11-14 Figure 15

[0053] ​​To couple the vial adapter 14d to the vial 16 via the first connector 34d, the vial adapter 14d and the vial 16 are initially aligned and pushed toward one another such that the spike element 22 is driven into and through the stopper 64 of the vial 16. When the spike element 22 is fully pushed through the stopper 64, the side arms 96 are vertically / axially aligned with the head portion 26 of the vial 16, with the head portion 26 positioned vertically between the first end 100 and the second end 102 of the side arms 96. With the vial adapter 14d positioned in the desired location relative to the vial 16, the user then grasps and pulls the free end 106 of the zip tie 98 secured to the flexible side arms 96, thereby reducing the size of the loop formed by the zip tie 98 and causing the second end 102 of each of the plurality of flexible side arms 96 to deflect radially inward. When the zip tie 98 is pulled tight by the appropriate amount, the flexible side arms 96 are brought into contact with the vial 16, with the side arms 96 wrapping around and clamping the head portion 26 and extending beneath the flange portion 110 on the underside of the head portion 26. Thus, the flexible side arms 96 provide a plurality of connection points between the first connector 34d and the vial 16 to securely hold the vial adapter 14d to the vial 16.

[0054] For the vial adapter 14d of Figures 11-15 it is recognized that other suitable actuation elements can be used in place of the zip tie 98 to apply a tension (radially inward) force to the flexible side arms 96 to cause the flexible side arms 96 to deflect. As one example, as shown in Figure 16 the actuation element can be provided as an elastic ring 112 that is sized and configured to apply a tension force to the flexible side arms 96 when positioned thereon. When it is desired to secure the vial adapter 14d to the vial 16 (after the spike element 22 has fully passed through the stopper 64 of the vial 16), the elastic ring 112 can be pulled apart by the user and positioned around the flexible side arms 96 and secured to the vial 16 via the engagement features 104 (e.g., hooks positioned on the outer surface of the side arms 96 adjacent the second end 102 of the side arms 96) formed on each of the plurality of flexible side arms 96, as shown in Figure 16As shown. With the elastic ring 112 secured to the flexible side arm 96, the elastic ring 112 is released by the user, thereby contracting from its stretched state back to its relaxed state, reducing the size of the ring formed by the elastic ring 112 and applying a contracting force that causes the second end 102 of each of the plurality of flexible side arms 96 to deflect radially inward. When the elastic ring 112 contracts / relaxes by an appropriate amount, the flexible side arm 96 is driven to contact the vial 16, wherein the side arm 96 surrounds and clamps the head portion 26 and extends below the flange portion 110 on the underside of the head portion 26. Thus, the flexible side arm 96 provides a plurality of connection points between the first connector 34d and the vial 16 to securely hold the vial adapter 14d to the vial 16.

[0055] Now for reference Figures 17-19 This illustrates a vial adapter 14e according to yet another aspect of this disclosure. Similar to the previously disclosed... Figures 2-16 The vial adapter shown, vial adapter 14e, includes a needle element 22 coupled to a base, a pressure equalization chamber 24, and a second connector 36. However, the base 114 in vial adapter 14e is specifically configured to receive a first connector 34e, which can engage with the base 114 to provide an external locking or coupling mechanism configured to engage or grip the head portion 26 of the vial 16.

[0056] like Figures 17-19 As shown, the base 114 of the vial adapter 14e includes a distal side 28 facing the vial 16 and a proximal side 30 facing the syringe adapter. However, the base 114 is also configured to include a pair of track housings 120 on the proximal side 30 of the base 114, wherein the track housings 120 define an opening through which multiple arms can be slidably translated, as explained in more detail below.

[0057] In the vial adapter 14e, the first connector 34e is configured as a track system including a pair of gripping arms 124 that slide relative to the actuating element 126 to bring the gripping arms 124 into contact with the vial 16. Based on the snap-fit ​​interaction between the track formed on the arm 124 and the toothed element (i.e., the actuating element 126 – hereinafter referred to as “toothed element 126”) formed on the track housing 120 of the base 114, the gripping arm 124 is referred to hereinafter as “snap-fit ​​arm 124”, which will be explained in further detail below.

[0058] The latching arms 124 are configured as generally C-shaped elements, each element having a first (or proximal) end 128 and a second (or distal) end 130, the first end extending through a corresponding track housing 120 of the base 114, the second end being vertically / axially spaced from and generally parallel to the first end 128, wherein the central portion 132 of the arm is orthogonal to and connects the first end 128 and the second end 130. The first end 128 and the second end 130 of each latching arm 124 are oriented generally parallel to the upper surface of the vial 16 and the bottom surface of the flange portion 110 of the head portion 26, the first end 128 and the second end 130 being spaced apart by a distance that accommodates the positioning of the head portion 26 of the vial 16 between the first end 128 and the second end 130 (i.e., within the channel 134 defined by the C-shaped latching arms 124).

[0059] like Figures 17-19 As shown, the first end 128 of each latching arm 124 includes a pair of grooved tracks 136, each grooved track including a series of alternating ridges and recesses on its upper surface. The pair of grooved tracks 136 are located on opposite sides of the latching arm 124 and are equidistant from opposite sides of the needle element 22 and the second connector 36. As the grooved track 136 slides radially inward and through the track housing 120, the grooved track 136 interacts with the toothed element 126 formed by the track housing 120. The toothed element 126 projects downward (distally) into the track housing 120, allowing it to engage the grooved track 136. As the grooved track 136 of each latching arm 124 slides radially inward and through the track housing 120, the grooved track 136 on each latching arm 124 interacts with the corresponding toothed element 126 via a snap-fit ​​or ratchet engagement that allows the grooved track 136 to move radially inward but prevents the grooved track 136 (and therefore the latching arm 124) from moving radially outward (i.e., the latching arm 124 is locked in place). In this way, the latching arm 124 can be moved from an initial position to an engaged position, in which the arm 124 is radially outwardly spaced from the head portion 26 of the vial 16, and in the engaged position, the arm 124 contacts the head portion 26 of the vial 16, wherein the head portion 26 is located in a channel 134 defined by the respective C-shaped latching arms of the plurality of C-shaped latching arms 124.

[0060] To couple the vial adapter 14e to the vial 16 via the first connector 34e, the vial adapter 14e and the vial 16 are initially aligned and pushed toward one another such that the spike element 22 is driven into and through the stopper 64 of the vial 16. When the spike element 22 is fully pushed through the stopper 64, the snap arms 124 are in vertical / axial alignment with the head portion 26 of the vial 16, where the head portion 26 is positioned vertically between the first end 128 and the second end 130 of the snap arms 124. With the vial adapter 14e positioned in the desired location relative to the vial 16, the user then pushes (“pinches”) the snap arms 124 radially inward from the initial position ( Figure 18 ) toward the engaged position ( Figure 19 ). As the slotted tracks 136 are pushed radially inward, the tooth elements 126 formed in the track housing 120 interact with the slotted tracks 136 of each snap arm 124. The snap arms 124 are pushed radially inward until they are brought into contact with the vial 16, where the head portion 26 of the vial is positioned in the passageway 134 defined by the individual ones of the plurality of C-shaped snap arms 124. With the snap arms 124 brought into this engaged position, the snap arms 124 are locked in place due to the configuration of the slotted tracks 136 and their interaction with the tooth elements 126, as the tooth elements 126 prevent the slotted tracks 136 and the snap arms 124 from moving radially outward. When in the engaged position, the snap arms 124 thus provide a plurality of connection points between the first connector 34e and the head portion 26 to securely hold the vial adapter 14e to the vial 16.

[0061] Advantageously, aspects of the present disclosure described herein provide a universal vial adapter that accommodates different types and / or sizes of vials as part of a closed system drug transfer device. The vial adapter includes a (first) connector for securing a vial to the vial adapter, where the connector is configured to engage an internal locking / coupling mechanism of a stopper of the vial or an external locking / coupling mechanism of a flanged head portion of the vial. The vial adapter is adapted for use with existing syringe adapters via a (second) connector thereon and provides a leak-proof seal during the process of the syringe adapter (and syringe connected thereto) being engaged with the vial via the vial adapter. The universal adapter eliminates the need for a medical facility to maintain multiple vial adapter configurations, thereby simplifying the workflow of the medical facility and reducing costs.

[0062] While the disclosure has been described in detail based upon the currently considered most practical and preferred embodiments or aspects, it is to be understood that this detail is for the purpose of illustration only and that the disclosure is not limited to the disclosed embodiments or aspects, but is intended to cover modifications and equivalents within the spirit and scope of the appended claims. For example, it is to be understood that the disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A medicine bottle adapter for connecting to a medicine bottle, the medicine bottle adapter comprising: A base, the base including a distal side and a proximal side, the base having a base lumen extending between the distal side and the proximal side; A first connector is located on the distal side of the base and configured to couple with the vial. A second connector is located on the proximal side of the base and is configured to couple to a fluid container; as well as A needle element extending distally from the base and configured to pierce the stopper of the vial, the needle element defining a needle lumen in fluid communication with the lumen of the base; The first connector is positioned on the needle element and includes an arm structure configured to engage with the stopper to secure the vial adapter to the vial.

2. The medicine bottle adapter according to claim 1, wherein, The first connector includes: A sleeve element, the sleeve element being positioned around the needle element and adjacent to the proximal end of the needle element so as to be close to the base, the sleeve element including a plurality of grooves formed in the sleeve element; Multiple preloaded arms forming the arm structure are positioned within the sleeve element, away from the needle element, and radially outwardly biased toward the sleeve element. The plurality of preload arms are rotatable relative to the sleeve, such that the end of each of the plurality of preload arms can be driven to align with the corresponding slot of the plurality of slots and be pushed out through the slot, such that a portion of each of the plurality of preload arms is positioned outside the sleeve element.

3. The medicine bottle adapter according to claim 2, wherein, When the needle element is inserted into the stopper, the sleeve element is held by the stopper to prevent the sleeve element from rotating relative to the stopper, and wherein subsequent rotation of the vial adapter causes the plurality of preload arms to be pushed out through the plurality of slots.

4. The vial adapter of claim 2, further comprising an adhesive applied to the outer surface of the sleeve element, the adhesive being configured to bond the sleeve element to the stopper.

5. The medicine bottle adapter according to claim 1, wherein, The first connector includes: An arm guide, which is positioned around the needle element and is translatable along the axial direction of the needle element; A plurality of expandable arms forming the arm structure, the plurality of expandable arms being configured to deflect radially inward and outward relative to the needle element, each of the plurality of expandable arms comprising: Connected to the distal end of the needle element; and The proximal end is movable within the arm guide.

6. The medicine bottle adapter according to claim 5, wherein, When the needle element is inserted into the plug, the arm guide is caused to translate proximally along the needle element such that the proximal end of each of the plurality of expandable arms is removed from the arm guide, wherein the plurality of expandable arms engage the plug and apply radially outward pressure to the plug.

7. The medicine bottle adapter according to claim 1, wherein, The arm structure of the first connector includes one or more cantilever retaining arms, each of which is connected to the distal end of the needle element adjacent to the needle element and is radially outwardly inclined away from the needle element; and Each of the one or more cantilever retaining arms is configured to deflect radially inward toward the needle element.

8. The medicine bottle adapter according to claim 7, wherein, The needle element is inserted into the plug such that the one or more cantilever retaining arms contact the plug and deflect radially inward; and When the needle element is fully pushed through the plug, the one or more cantilever retaining arms are positioned on the distal side of the plug and move radially outward back to their default position, wherein the one or more cantilever retaining arms engage with the rear surface of the plug.

9. The medicine bottle adapter according to claim 1, wherein, The second connector includes a connector lumen that extends through the second connector and is in fluid communication with the base lumen and the needle lumen.

10. The medicine bottle adapter according to claim 1, wherein, The needle element includes an exhaust cavity formed therein, and the vial adapter further includes a pressure balancing element coupled to the base and in fluid communication with the exhaust cavity.

11. A medicine bottle adapter for connecting to a medicine bottle, the medicine bottle adapter comprising: A base, the base including a distal side and a proximal side, the base having a base lumen extending between the distal side and the proximal side; A first connector is located on the distal side of the base and is configured to couple with a plug; A second connector is located on the proximal side of the base and is configured to couple to a fluid container; as well as A needle element extending distally from the base and configured to pierce the stopper of the vial, the needle element defining a needle lumen in fluid communication with the lumen of the base; The first connector includes: A plurality of gripping arms, the plurality of gripping arms extending distally and radially outward from the base, each of the plurality of gripping arms having a first end connected to or engaged with the base and a second end opposite to the first end; and An actuating element, which can be activated by a user to move the second end of each of the plurality of gripping arms radially inward, thereby causing the plurality of gripping arms to contact the medicine bottle to secure the medicine bottle adapter to the medicine bottle.

12. The medicine bottle adapter according to claim 11, wherein, Each of the plurality of gripping arms includes a flexible side arm configured to deflect radially inward.

13. The medicine bottle adapter according to claim 12, wherein, The actuating element includes a zipper strap that loops through an engagement feature formed on each sidewall of the plurality of side arms, and wherein tightening the zipper strap causes a second end of each sidewall of the plurality of side arms to deflect radially inward and contact the vial.

14. The medicine bottle adapter according to claim 13, wherein, The joining feature includes one of the following: A hook or channel is formed near the second end of the side arm, which secures the zipper strap to the side arm. or One or more holes are formed in the side arm, through which the zipper strap passes to secure the zipper strap to the side arm.

15. The vial adapter of claim 12, wherein the actuating element includes a resilient ring, the resilient ring engaging with a second end of each of the plurality of side arms, and wherein, The elastic ring applies a contractile force that causes the second end of each of the plurality of side arms to deflect radially inward and come into contact with the vial.

16. The medicine bottle adapter according to claim 11, wherein, The first connector includes a track system, the plurality of gripping arms include a plurality of snap-fit ​​arms, each snap-fit ​​arm includes a pair of grooved tracks formed at a first end of the snap-fit ​​arm, and the actuating element includes a toothed element disposed on a track housing positioned on the proximal side of the base, the toothed element and the grooved tracks interact to move the plurality of snap-fit ​​arms radially inward.

17. The medicine bottle adapter according to claim 16, wherein, Each of the plurality of latching arms includes a generally C-shaped element, the first end of which is oriented parallel to the upper surface of the vial and has a grooved track formed thereon, and the second end of which is oriented parallel to the first end.

18. The medicine bottle adapter according to claim 17, wherein, The first end and the second end are spaced apart by a distance that accommodates the positioning of the head portion of the vial within the channel defined by the C-shaped gripping arm.

19. The medicine bottle adapter according to claim 16, wherein, The plurality of latching arms are capable of radially inward movement relative to the base, and wherein, when the plurality of latching arms are capable of radially inward movement and contact the medicine bottle, the engagement of the toothed element with the grooved track locks the plurality of latching arms into place.

20. The medicine bottle adapter according to claim 11, wherein, The needle element includes an exhaust cavity formed therein, and the vial adapter further includes a pressure balancing element coupled to the base and in fluid communication with the exhaust cavity.

Images