Medical vial adapter with reduced diameter cannula and enlarged vent lumen
View Patent ↗A vented vial adapter for reconstitution of a medicament in a vial includes a vent lumen and a medicament lumen. The vent lumen has a cross-sectional area equal to or greater than that of the medicament lumen so that the fluid flow rate through the vent lumen is equal to or greater than that of the medicament lumen. As a result aerosols of the medicament outside the adapter are avoided as is the withdrawal of air bubbles from the vial as the reconstituted medicament is withdrawn from the vial. To maintain the diameter of the sharpened cannula of the vial adapter as small as possible, the vent lumen includes a concave wall facing the medicament lumen and a convex outer wall. In one embodiment, the vent lumen is in the shape of a polygon.
1. A vial adapter for accessing a vial having a vial closure that includes a pierceable seal located over an opening of the vial, the adapter comprising:
a housing having an attachment device to engage the vial for secure mounting of the vial adapter to the vial;
a body portion having a medicament port and a vent port with a medicament lumen leading to the medicament port and a vent lumen leading to the vent port, the medicament and vent lumina being separate from each other; and
a cannula located within the housing having a sharpened tip for piercing the seal of the vial closure to provide access to vial contents, the cannula having a medicament lumen in fluid communication with the body medicament lumen and a vent lumen in fluid communication with the body vent lumen, the cannula medicament lumen and cannula vent lumen having respective openings disposed on the sharpened cannula;
wherein the cannula vent lumen has an inner wall and an outer wall, the inner wall is positioned closer with respect to the cannula medicament lumen than the outer wall is positioned with respect to the cannula medicament lumen, and wherein the cannula vent lumen is at least partially wrapped around the medicament lumen, and wherein the cross-sectional area of the cross-sectional shape of the cannula vent lumen is equal to or greater than the cross-section of the area of a cross-sectional shape of the cannula medicament lumen so that the flow rate of air through the body and cannula vent lumina is at least as great as a flow rate of medicament through the combination of the body and cannula medicament lumina.
2. The vial adapter of claim 1 wherein the generally concave cross-sectional shape of the inner wall of the cannula vent lumen comprises an angulation, a vertex of which is oriented toward the outer wall of the cannula vent lumen.
3. The vial adapter of claim 2 wherein the outer wall of the cannula vent lumen has a generally convex cross-sectional shape.
4. The vial adapter of claim 3 wherein the generally convex outer wall and generally concave inner wall are interconnected by two side walls.
5. The vial adapter of claim 4 wherein the side walls are substantially straight but are not aligned on a radius from longitudinal center line of the sharpened cannula.
6. The vial adapter of claim 1 wherein the cross-sectional shape of the inner wall of the cannula vent lumen comprises linear portions forming an obtuse angle, the vertex of which faces an outer wall.
7. The vial adapter of claim 1 wherein the inner wall of the cannula vent lumen is oriented to face the cannula medicament lumen whereby the cannula vent lumen may be positioned closer to the cannula medicament lumen within the cannula to result in a smaller diameter cannula yet a vent lumen that is at least as large as the medicament lumen.
8. The vial adapter of claim 1 wherein:
the cross-sectional shape of the cannula medicament lumen is generally circular; and
the cross-sectional shape of the inner wall of the cannula vent lumen comprises linear portions forming an obtuse angle, the inner wall oriented to face the cannula medicament lumen;
whereby the cannula vent lumen may be positioned closer to the cannula medicament lumen within the cannula to result in a smaller diameter cannula yet a vent lumen that is at least as large as the medicament lumen.
9. The vial adapter of claim 1 wherein the opening of the cannula vent lumen on the cannula is closer to the sharpened tip than is the opening of the cannula medicament lumen on the cannula.
10. The vial adapter of claim 1 further comprising a needle free valve disposed at the medicament port of the body adapted to control the flow of fluid through the medicament lumina.
11. The vial adapter of claim 1 further comprising a filter disposed at the vent port of the body adapted to control the flow of fluid through the vent lumina.
12. The vial adapter of claim 11 wherein the filter comprises an hydrophilic filter.
13. The vial adapter of claim 11 wherein the filter comprises an anti-bacterial filter.
14. The vial adapter of claim 1 wherein the cannula medicament lumen comprises a cross-sectional shape in the form of a polygon having an inner wall, an outer wall, and at least one side wall interconnecting the inner and outer walls.
15. The vial adapter of claim 14 wherein the cannula medicament lumen is located at a longitudinal centerline of the sharpened cannula.
16. The vial adapter of claim 14 wherein the outer wall of the cannula vent lumen has a generally convex cross-sectional shape.
17. The vial adapter of claim 16 wherein the generally convex outer wall and generally concave inner wall are interconnected by two side walls.
18. The vial adapter of claim 17 wherein the side walls are substantially straight but are not aligned on a radius from a longitudinal center line of the sharpened cannula.
19. The vial adapter of claim 14 wherein the generally concave inner wall shape of the cross section of the cannula vent lumen includes at least one angulation facing the outer wall.
20. The vial adapter of claim 3 wherein the connecting side wall is non-radial in relation to a longitudinal center line of the sharpened cannula.
21. The vial adapter of claim 1 further comprising an open channel formed longitudinally in an outer surface of the cannula from approximately the sharp tip to be in fluid communication with the medicament opening.
22. A method for accessing a vial having a vial closure that includes a pierceable seal located over an opening of the vial, the method comprising:
piercing the seal with a sharpened cannula having a medicament lumen and a vent lumen separate from each other wherein the cannula vent lumen has an inner wall and an outer wall, the inner wall is positioned closer with respect to the cannula medicament lumen than the outer wall is positioned with respect to the cannula medicament lumen, and wherein the cannula vent lumen is at least partially wrapped around the medicament lumen, and the cross sectional area of the cross-sectional shape of the vent lumen is equal to or greater than the cross-sectional area of the cross-sectional shape of the medicament lumen so that the flow rate of air through the vent lumen is at least as great as a flow rate of medicament through the medicament lumen;
mounting a housing having an attachment device to the vial to secure the vial adapter to the vial and the sharpened cannula through the seal, the sharpened cannula being disposed within the housing; and
communicating fluid through the sharpened cannula and through a body portion that is in fluid communication with the cannula, the body portion having a body medicament lumen in fluid communication with the cannula medicament lumen and having a medicament port, and a body vent lumen in fluid communication with the cannula vent lumen and having a vent port, the body medicament and vent lumina being separate from each other.
23. The method of claim 22 further comprising controlling the flow of fluid through the medicament port of the body with a needle free connector having a valve.
24. The method of claim 22 further comprising controlling the flow of fluid through the body portion with a filter disposed in communication with the vent port.
25. The method of claim 24 wherein the step of controlling the flow of fluid comprises controlling the flow of liquid through the body with an hydrophobic filter mounted in communication with the vent port.
26. The method of claim 24 wherein the step of controlling the flow of fluid comprises controlling the flow of airborne agents through the body with an anti-bacterial filter mounted in communication with the vent port.
27. A vial adapter for accessing a vial having a vial closure that includes a pierceable seal located over an opening of the vial, the adapter comprising:
a body portion having a medicament port and a vent port with a medicament lumen leading to the medicament port and a vent lumen leading to the vent port, the medicament and vent lumina being separate from each other; and
a cannula mounted to the body and having a sharpened tip for piercing the seal of the vial closure to provide access to vial contents, the cannula having a medicament lumen in fluid communication with the body medicament lumen and a vent lumen in fluid communication with the body vent lumen, the cannula medicament lumen and cannula vent lumen having respective openings disposed on the sharpened cannula;
wherein the cannula vent lumen has an inner wall and an outer wall, the inner wall is positioned closer with respect to the cannula medicament lumen than the outer wall is positioned with respect to the cannula medicament lumen, and wherein the cannula vent lumen is at least partially wrapped around the medicament lumen, and wherein the cross-sectional area of the cross-sectional shape of the cannula vent lumen is equal to or greater than the cross-sectional area of a cross-sectional shape of the cannula medicament lumen so that the flow rate of air through the body and vent lumina is at least as great as a flow rate of medicament through the combination of the body and cannula medicament lumina.
28. The vial adapter of claim 27 , wherein the cannula further comprises a slot formed in a side of the cannula from the sharpened tip to the cannula medicament lumen opening to guide fluid to the cannula medicament lumen opening.
29. The vial adapter of claim 1 , wherein the cannula further comprises:
a slot formed in a side of the cannula from the sharpened tip to the cannula medicament lumen opening to guide fluid to the cannula medicament lumen opening.
30. The method of claim 22 , further comprising:
guiding fluid to the cannula medicament lumen opening using a slot formed in a side of the cannula to a cannula medicament opening.