IP Library Granted Patent US 11,129,773
Granted Patent B2
US 11,129,773 · App. 16/872,754 · Granted Sep 28, 2021

Pressure-regulating vial adaptors

Inventor: Thomas F. Fangrow (Mission Viejo, CA)
Assignee: ICU Medical, Inc.
A61J1/2096A61J1/201A61J1/2048A61J1/2075A61J1/2082A61J1/2086B65B3/003A61J1/10Y10T29/49826
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Quick Facts
Patent No.
US 11,129,773
App. No.
16/872,754
Granted
Sep 28, 2021
Kind
B2
Abstract

In certain embodiments, a vial adaptor comprises a housing configured to couple the adaptor with a vial, an access channel, a regulator channel, and a regulator assembly. The access channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. The regulator channel is configured to facilitate a flow of a regulating fluid from the regulator assembly to compensate for changes in volume of a medical fluid in the vial. In some embodiments, the regulator assembly includes a flexible member configured to expand and contract in accordance with changes in the volume of the medical fluid in the vial. In some embodiments, the flexible member is substantially free to expand and contract. In some embodiments, the flexible member is not partly or completely located in a rigid enclosure.

Claims (49)

1. A vial adapter comprising:

a housing configured to couple with a vial having a septum;

a piercing member configured to be inserted through the septum of the vial;

an access channel configured to convey medical fluid;

a regulator channel configured to convey regulating fluid;

a rigid enclosure comprising an internal space bounded by an inner surface of the rigid enclosure, at least a portion of the inner surface of the rigid enclosure in fluid communication with the ambient environment when the housing is coupled with the vial; and

a reservoir comprising a first flexible side and a second flexible side, the reservoir configured to move from a deflated state to an inflated state in response to regulating fluid being received between the first and second flexible sides, wherein:

in the deflated state and with the housing coupled with the vial, the reservoir is positioned in the internal space of the rigid enclosure and outside of the vial; and

in the inflated state, a portion of the reservoir has expanded out of the internal space.

2. The vial adapter of claim 1 , further comprising a flexible annular ring coupled to the rigid enclosure.

3. The vial adapter of claim 2 , wherein the flexible annular ring comprises a stretchable material.

4. The vial adapter of claim 1 , further comprising an outer wall that is located on a side of the chamber opposite a connection between the reservoir and the regulator channel, the outer wall comprising a central opening.

5. The vial adapter of claim 1 , wherein the rigid enclosure further comprises a vent that faces away from the housing.

6. The vial adapter of claim 5 , wherein the vent has a diameter that is less than an outside diameter of the reservoir.

7. The vial adapter of claim 1 , wherein a majority of the reservoir is positioned inside the rigid enclosure.

8. The vial adapter of claim 1 , wherein, in the deflated state, the reservoir comprises a plurality of folds.

9. The vial adapter of claim 1 , further comprising:

a valve configured to open to allow ambient air to enter the vial adapter; and

a filter configured to filter the ambient air allowed to enter the vial adapter.

10. The vial adapter of claim 1 , wherein the reservoir comprises a metalized coating or metal component.

11. A vial adapter comprising:

a housing configured to couple with a vial having a septum;

a piercing member configured to be inserted through the septum of the vial;

an access channel configured to convey medical fluid;

a regulator channel configured to convey regulating fluid;

a rigid enclosure; and

a reservoir comprising a first flexible side and a second flexible side, the reservoir in communication with the regulator channel and at least partially contained within the rigid enclosure,

the reservoir configured such that, with the housing coupled to the vial, in response to regulating fluid being conveyed from the regulator channel into the reservoir, the reservoir moves from a deflated state to an inflated state and a portion of the reservoir expands out of the rigid enclosure and into the ambient environment outside of the vial,

wherein a height of the reservoir, as measured parallel to a longitudinal axis of the piercing member, is greater in the inflated state than in the deflated state.

12. The vial adapter of claim 11 , further comprising a flexible annular ring coupled to the rigid enclosure.

13. The vial adapter of claim 11 , further comprising:

a one-way valve configured to open to allow ambient air to enter the vial adapter; and

a filter configured to filter the ambient air allowed to enter the vial adapter.

14. The vial adapter of claim 11 , further comprising a two-way valve configured to allow regulating fluid to flow into the reservoir at a first cracking pressure and out of the reservoir at a second cracking pressure, the second cracking pressure being different than the first cracking pressure.

15. A vial adapter comprising:

a housing configured to couple with a vial having a septum;

a piercing member configured to be inserted through the septum of the vial;

an access channel configured to convey medical fluid;

a regulator channel configured to convey regulating fluid; and

a reservoir comprising a first flexible side and a second flexible side, the reservoir configured to move from a deflated state to an inflated state in response to regulating fluid being transferred from the vial and received between the first and second flexible sides of the reservoir, wherein:

in the course of movement from the deflated state to the inflated state, a top of the reservoir expands upward and a bottom of the reservoir expands downward; and

in the inflated state, the reservoir has an oblate spheroidal shape.

16. The vial adapter of claim 15 , further comprising a rigid enclosure, wherein at least a part of the reservoir is positioned in the rigid enclosure in the deflated state.

17. The vial adapter of claim 16 , wherein the reservoir is further configured such that, in the course of movement from the deflated state to the inflated state, a portion of the reservoir expands out of the rigid enclosure.

18. The vial adapter of claim 17 , further comprising a flexible annular ring coupled to the rigid enclosure.

19. The vial adapter of claim 15 , wherein further comprising:

a one-way valve configured to open to allow ambient air to enter the vial adapter; and

a filter configured to filter the ambient air allowed to enter the vial adapter.

20. The vial adapter of claim 15 , further comprising a two-way valve configured to allow regulating fluid to flow into the reservoir at a first cracking pressure and out of the reservoir at a second cracking pressure, the second cracking pressure being different than the first cracking pressure.

Assignments (1)
SECURITY AGREEMENT Recorded Mar 31, 2022
From: ICU MEDICAL, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 059618/0412 →
Continuity (7)
Continuation 15932248 · Feb 16, 2018
Continuation 14789806 · Jul 1, 2015
Continuation 14179475 · Feb 12, 2014
Continuation PCTUS2012051226 · Aug 16, 2012
Provisional Application 61525126 · Aug 18, 2011
Provisional Application 61614250 · Mar 22, 2012
Related Publication 20200337948A1 · Oct 29, 2020
Cited By (11)
US 12,280,013 US 12,350,234 US 12,350,237 US 12,370,125 US 12,377,022 US 12,383,469 US 12,414,899 US 12,508,208 US 12,521,311 US 12,544,309 US 12,629,318