Modular vial adapter

Patent metadata

Field	Value
Publication number	US-12239609-B2
Application number	US-202117338209-A
Country	US
Kind code	B2
Filing date	Jun 3, 2021
Priority date	Dec 13, 2016
Publication date	Mar 4, 2025
Grant date	Mar 4, 2025

Abstract

The present disclosure is directed to a vial adapter for interconnecting a vial and a fluid delivery device, and, more particularly, to a vial adapter having a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new vial adapter configurations that meet specific needs.

First claim

What is claimed is:

1. A modular vial adapter for interconnecting a vial with a delivery device, the modular vial adapter comprising:
a spike member comprising a base and a distal tip extending therefrom, the spike member further comprising at least a first lumen extending from the base to the distal tip and providing a fluid pathway therethrough;
a separately formed port member comprising a first end defining a base directly coupled to the base of the spike member and an opposing second end defining a connector assembly, the port member further comprising a channel extending therethrough from the first end to the second end and in fluid communication with the fluid pathway of the first lumen of the spike member upon coupling of spike member base with the base of the port member; and
a separately formed skirt member comprising a proximal end defining a base including a recess having a bore extending therethrough, wherein the recess is shaped and/or sized for receiving and retaining portions of the spike member and port member therein,
wherein, upon positioning of a vial closure within a cavity of the skirt member, the distal tip of the spike member is configured to penetrate a seal of the vial and fluid content within the vial is available for transfer to a delivery device releasably coupled to at least the connector assembly of the port member via the fluid pathway from the distal tip of the spike member through the channel of the port member and out of the connecter assembly of the port member, and
wherein, when the spike member, the port member, and the skirt member are unassembled, at least one of the spike member, the port member, or the skirt member is interchangeable with a plurality of other components having one of different dimensions, characteristics, components, or materials than the at least one of the spike member, the port member, or the skirt member.

2. The modular via adapter of claim 1 , wherein the spike member further comprises:
a second lumen separate from the first lumen and having a first open end proximate the base and a second open end proximate the distal tip, the first open end being positioned external to the modular vial adapter such that the second lumen provides a vent pathway to the distal tip.

3. The modular via adapter of claim 2 , wherein the vent pathway allows for atmospheric air to enter an interior space of the vial to prevent negative pressure buildup when fluid content is transported from the vial via the fluid pathway provided by the first lumen.

4. The modular via adapter of claim 2 , wherein the first open end of the second lumen is positioned at 45° with respect to the vent pathway.

5. The modular via adapter of claim 4 , further comprising a vent filter positioned at the first open end of the second lumen.

6. The modular via adapter of claim 5 , wherein the vent filter is ultrasonically welded onto the base of the spike member at the first open end of the second lumen.

7. The modular vial adapter of claim 1 , wherein the recess maintains a position of the distal tip of the spike member within the cavity for engagement with a vial seal upon receipt of the vial closure within the cavity of the skirt member.

8. The modular vial adapter of claim 7 , wherein the connector assembly of the port member extends through the bore defined in the recess of the skirt member to thereby allow the connector assembly to be coupled to the delivery device for subsequent transport of fluid content from the vial.

9. The modular vial adapter of claim 1 , wherein the skirt member further comprises at least one side wall extending from the base and terminating at an open distal end to define the cavity shaped and/or sized to receive and engage the vial closure.

10. The modular vial adapter of claim 9 , wherein the at least one side wall comprises at least one detent extending from an inner surface thereof, the at least one detent being sized and shaped to engage the closure of the vial.

11. The modular vial adapter of claim 9 , wherein the at least one side wall comprises a flange having a first diameter greater than a second dimeter of the cavity of the skirt member.

12. The modular vial adapter of claim 1 , wherein the skirt member comprises an external surface having one or more grip portions.

13. The modular vial adapter of claim 1 , wherein the skirt comprises at least one protrusion extending from a proximal end thereof, the protrusion being sized and shaped to engage a corresponding and mating geometry of a delivery device for maintaining alignment and limiting rotation of the assembled adapter in a visible, tactile, or audible manner.

14. A method comprising:
selecting a first port member of a plurality of port members, wherein each of the plurality of port members comprises a first base member at a first end and a connector assembly at a second end, wherein each of the plurality of port members have at least one of different dimensions, characteristics, components, or materials;
contacting the first base member of the first port member to a second base member of a spike member, thereby creating a port/base assembly;
inserting the port/base assembly into a recess of a skirt member;
attaching the port/base assembly to the skirt member such that a spike of the spike member extends into a cavity of the skirt member;
positioning a vial closure within the cavity of the skirt member such that the spike of the spike member penetrates a seal of the vial closure; and
attaching a fluid delivery device to the connector assembly of the first port member.

15. The method of claim 14 , further comprising:
selecting the spike member from a plurality of spike members, wherein each of the plurality of spike members have at least one of different dimensions, characteristics, components, or materials that are connectable with the plurality of port members.

16. The method of claim 14 , further comprising:
selecting the skirt member from a plurality of skirt members, wherein each of the plurality of skirt members have at least one of different dimensions, characteristics, components, or materials that are connectable with the plurality of port members.

17. The method of claim 14 , wherein positioning the vial closure within the cavity of the skirt member further comprises:
positioning the vial closure within a side wall extending from a base of the skirt member and terminating at an open distal end to define the cavity.

18. The method of claim 17 , further comprising advancing the vial closure beyond a detent extending from an inner surface of the side wall.

19. The method of claim 17 , wherein the side wall comprises a flange having a first diameter greater than a second dimeter of the cavity of the skirt member.

20. The method of claim 14 , further comprising holding grip portions of the skirt member while positioning the vial closure within the cavity of the skirt member.

Assignees

• Takeda Pharmaceuticals Co

Inventors

• Ariagno Scott Richard
• Roush Daniel Edward

Classifications

• A61J1/14

  Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00) · CPC title

• A61M39/10

  Tube connectors; Tube couplings {(A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014)} · CPC title

• A61M5/162 Primary

  Needle sets, i.e. connections by puncture between reservoir and tube {; Connections between reservoir and tube (in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14)} · CPC title

• A61J1/20

  Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe · CPC title

• A61J1/201

  having one piercing end · CPC title