Universal adapter for closed system drug transfer devices

Abstract

Provided herein is a vial adapter for accessing a vial. The vial adapter includes a base having a distal and a proximal side, the base lumen extending between the distal and proximal sides. The vial adapter also includes a first connector located distal to the base and configured to connect to a vial, a second connector located proximal to the base and configured to connect to a fluid container, and a spike member extending distally from the base and configured to penetrate a stopper on the vial, the spike member defining a spike lumen that communicates with the base lumen and the fluid. The first connector includes an arm structure located on the spike member and configured to engage with a stopper to secure the vial adapter to the vial.

Claims

1. A vial adapter for accessing vials, A base including a distal side and a proximal side, having a base lumen extending between the distal side and the proximal side, A first connector is positioned on the distal side of the base and configured to connect with the vial, A second connector is positioned on the proximal side of the base and configured to connect to a fluid container, A spike member extending distally from the base and configured to penetrate the stopper of the vial, the spike member defining a spike lumen that is in fluid communication with the base lumen, Equipped with, The first connector is a vial adapter for accessing a vial, comprising an arm structure positioned on the spike member and configured to engage with the stopper to secure the vial adapter to the vial.

2. The first connector described above is A sleeve member positioned around the spike member and adjacent to the proximal end of the spike member so as to abut the base, the sleeve member comprising a plurality of slots formed therein, The arm structure comprises a plurality of preloaded arms, each positioned within the sleeve member and biased radially outward toward the sleeve member, away from the spike member, The vial adapter according to claim 1, wherein each end of the plurality of preloaded arms is aligned with each slot of the plurality of slots and is actuated through the slots, and the plurality of preloaded arms are rotatable relative to the sleeve such that a portion of each of the plurality of preloaded arms is positioned outside the sleeve member.

3. The vial adapter according to claim 2, wherein when the spike member is inserted into the stopper, the sleeve member is held by the stopper, preventing the sleeve member from rotating relative to the stopper, and the subsequent rotation of the vial adapter causes the plurality of preloaded arms to actuate through the plurality of slots.

4. The vial adapter according to claim 2, further comprising an adhesive applied to the outer surface of the sleeve member, wherein the adhesive is configured to bond the sleeve member to the stopper.

5. The first connector described above is An arm guide is positioned around the spike member and is capable of axial translation along the spike member, A plurality of extendable arms forming the arm structure, configured to bend radially inward and outward relative to the spike member, and each of the plurality of extendable arms is The distal end joined to the spike member, A plurality of extendable arms, each including a proximal end movable within the arm guide, The vial adapter according to claim 1, comprising:

6. The vial adapter according to claim 5, wherein when the spike member is inserted into the stopper, the proximal end of each of the plurality of expandable arms is disengaged from the arm guide, the plurality of expandable arms engage with the stopper, and the arm guide is moved in a parallel direction along the spike member so as to apply radially outward pressure to the stopper.

7. The arm structure of the first connector includes one or more cantilevered retaining arms, each of which is joined to the spike member adjacent to the distal end of the spike member and angled radially outward from the spike member. The vial adapter according to claim 1, wherein each of the one or more cantilevered holding arms is configured to bend radially inward toward the spike member.

8. By inserting the spike member into the stopper, one or more cantilevered holding arms come into contact with the stopper and are bent radially inward. The adapter according to claim 7, wherein when the spike member penetrates the stopper and is fully pushed in, the one or more cantilevered retaining arms return to their default position distal to the stopper and radially outward, and the one or more cantilevered retaining arms engage with the back surface of the stopper.

9. The vial adapter according to claim 1, wherein the second connector comprises a connector lumen that extends through the second connector and is in fluid communication with the base lumen and the spike lumen.

10. The vial adapter according to claim 1, wherein the spike member includes a vented lumen formed therein, and the vial adapter further comprises a pressure equalizing member coupled to the base and in fluid communication with the vented lumen.

11. A vial adapter for accessing vials, A base including a distal side and a proximal side, wherein the base has a base lumen extending between the distal side and the proximal side, A first connector is positioned on the distal side of the base and configured to connect with the vial, A second connector is positioned on the proximal side of the base and configured to connect to a fluid container, A spike member extending distally from the base and configured to penetrate the stopper of the vial, comprising a spike member that defines a spike lumen in fluid communication with the base lumen, The first connector described above is A plurality of gripping arms extending distally and radially outward from the distal side of the base, wherein each of the plurality of gripping arms has a first end that connects to or engages with the base, and a second end opposite to the first end, A vial adapter comprising: an actuation member that can be engaged by a user to fix the vial adapter to the vial, by moving the second end of each of the plurality of gripping arms radially inward, thereby bringing the plurality of gripping arms into contact with the vial.

12. The vial adapter according to claim 11, wherein each of the plurality of gripping arms is provided with a flexible side arm configured to bend radially inward.

13. The vial adapter according to claim 12, wherein the operating member includes a zip tie formed into a loop through an engagement mechanism formed on each of the plurality of side arms, and tightening the zip tie bends the second end of each of the plurality of side arms radially inward, bringing it into contact with the vial.

14. The engagement mechanism is A hook or channel is formed adjacent to the second end of the side arm for securing the zip tie to the side arm, or The vial adapter according to claim 13, comprising one or more holes formed in the side arm, the zip tie passing through each of the one or more holes and securing the zip tie to the side arm.

15. The vial adapter according to claim 12, wherein the operating member includes an elastomer ring that engages with each of the plurality of side arms at its second end, and the elastomer ring applies a contractile force that bends each of the plurality of side arms radially inward and brings it into contact with the vial.

16. The vial adapter according to claim 11, wherein the first connector includes a track system, the plurality of gripping arms each include a pair of grooved tracks formed at the first end thereof, the actuating member includes a toothed member provided on the track housing located proximal to the base, and the toothed member and the grooved tracks interact to allow radially inward movement of the plurality of snap arms.

17. The vial adapter according to claim 16, wherein each of the plurality of snap arms includes a generally C-shaped member, the first end of which is positioned parallel to the upper surface of the vial and the grooved track formed thereon, and the second end of which is positioned parallel to the first end.

18. The vial adapter according to claim 17, wherein the first end is spaced apart from the second end by a distance corresponding to the placement of the head of the vial into a channel defined by the C-shaped gripping arm.

19. The vial adapter according to claim 16, wherein the plurality of snap arms are movable radially inward with respect to the base, and when the plurality of snap arms are movable radially inward, the engagement between the toothed member and the grooved track fixes the plurality of snap arms in a predetermined position when in contact with the vial.

20. The vial adapter according to claim 11, wherein the spike member includes a vented lumen formed therein, and the vial adapter further comprises a pressure equalizing member coupled to the base and in fluid communication with the vented lumen.

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