Modular vial adapter

Patent metadata

Field	Value
Publication number	US-11033459-B2
Application number	US-201715840004-A
Country	US
Kind code	B2
Filing date	Dec 13, 2017
Priority date	Dec 13, 2016
Publication date	Jun 15, 2021
Grant date	Jun 15, 2021

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; and
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 for allowing 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 of the first lumen;

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 port member base; 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, the skirt member further comprising at least one side wall extending from the base and terminating at an open distal end to define a cavity shaped and/or sized to receive and engage a closure on a vial,
wherein, upon positioning of a vial closure within the 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, port member, and skirt member are unassembled, the port member is interchangeable with one of a plurality of other port members, each of the plurality of other port members having at least one of different dimensions, characteristics, components, and materials.

2. The modular vial adapter of claim 1 , wherein, prior to assembly of the spike member, port member, and skirt member with one another, the spike member is interchangeable with one of a plurality of other spike members.

3. The modular vial adapter of claim 2 , wherein the plurality of other spike members have at least one of different dimensions, characteristics, components, and materials.

4. The modular vial adapter of claim 1 , wherein, prior to assembly of the spike member, port member, and skirt member with one another, the skirt member is interchangeable with one of a plurality of other skirt members.

5. The modular vial adapter of claim 4 , wherein the plurality of other skirt members have at least one of different dimensions, characteristics, components, and materials.

6. The modular vial adapter of claim 1 , wherein, when the spike member and port member are received in the recess, the position of distal tip of the spike member is maintained within the cavity for engagement with the vial seal upon receipt of the vial closure within the cavity of the skirt member.

7. The modular vial adapter of claim 6 , 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.

8. The modular vial adapter of claim 6 , wherein the at least one side wall comprises at least one detent extending from an inner surface thereof, the at least one detent is configured to engage the closure of the vial to retain the closure within the cavity once positioned therein.

9. The modular vial adapter of claim 6 , wherein the skirt member comprises an external surface having one or more grip portions.

10. The modular vial adapter of claim 1 , wherein the vent pathway allows for atmospheric air to enter the 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.

11. The modular vial adapter of claim 1 , further comprising a vent filter coupled to the second open end of the second lumen.

12. The modular vial adapter of claim 11 , wherein the filter comprises a hydrophobic material having a pore size of 0.1 microns to 5 microns.

13. The modular vial adapter of claim 1 , wherein the connector assembly of the port member comprises a delivery device-specific connection fitting, wherein the delivery device comprises a pump and/or injector assembly.

14. The modular vial adapter of claim 1 , wherein the channel of the port member comprises a channel opening formed on a distal end thereof opposite the connector assembly and adjacent to the base, wherein the channel opening is shaped and/or sized to receive and retain a separately formed fluid filter membrane within.

15. The modular vial adapter of claim 14 , wherein the filter comprises a material having a pore size of 5 microns to 150 microns.

16. The modular vial adapter of claim 1 , wherein the skirt comprises at least one protrusion extending from a proximal end thereof and configured 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.

Assignees

• Shire Human Genetic Therapies

Inventors

• Ariagno Scott Richard
• Roush Daniel Edward

Classifications

• 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

• A61J1/14

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

• A61J1/20

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

• A61J1/2082

  for gas filtration · CPC title