Anti-reflux vial adaptors

• US 9,931,275 B2
• Filed: 05/26/2016
• Issued: 04/03/2018
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Kidwell, Michele M
• Assistant Examiner(s): TREYGER, ILYA Y
• Application Number:
  US15/165,761
• Publication Number:
  US 20160338911A1
• Time in Patent Office: 677 Days
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

In certain embodiments, a vial adaptor comprises a housing member, a connector configured to couple the adaptor with a vial, and an extractor channel formed in the housing member. The extractor channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. In some embodiments, an anti-reflux valve is positioned within the extractor channel. The anti-reflux valve can be configured to impede or obstruct fluid returning to a fluid source after withdrawal of the fluid from the fluid source.

Claims

1. A vial adaptor comprising:

a medical connector interface configured to connect the vial adaptor to a syringe, wherein the syringe has a barrel and a plunger disposed within the barrel;

a piercing member;

an extractor channel at least partially defined by the piercing member;

an extractor aperture in fluid communication with the medical connector interface; and

a valve positioned within the extractor channel, the valve configured to resist unintended movement of the plunger when the syringe is connected to the medical connector interface;

wherein the vial adaptor is configured to be coupled with a vial containing a medicinal fluid, such that at least a portion of the extractor channel is in fluid communication with the medicinal fluid contained in the vial when the vial adaptor is coupled to the vial;

wherein the extractor channel is configured to facilitate transfer of the medicinal fluid between the vial adaptor and the vial when the vial adaptor is coupled to the vial;

wherein the valve permits the medicinal fluid to flow into the vial and away from the vial when the vial adaptor is coupled to the vial;

wherein the valve has a first cracking pressure for allowing fluid flow away from the vial and a second cracking pressure for allowing fluid flow towards the vial; and

wherein the second cracking pressure is greater than the first cracking pressure, such that the cracking pressure of the valve is greater in the direction of fluid flow towards the vial than in the direction of fluid flow away from the vial.

2. The vial adaptor of claim 1, wherein the valve is an anti-reflux valve.

3. The vial adaptor of claim 1, wherein the valve is configured to permit the medicinal fluid to be withdrawn from the vial more easily than for the medicinal fluid to be added to the vial when the vial adaptor is coupled to the vial.

4. The vial adaptor of claim 2, wherein the anti-reflux valve is configured to impede or obstruct the medicinal fluid returning to the vial after withdrawal of at least some of the medicinal fluid from the vial when the vial adaptor is coupled to the vial.

5. The vial adaptor of claim 2, wherein the anti-reflux valve is a dome-shaped valve.

6. The vial adaptor of claim 1, wherein the valve comprises elastomeric rubber.

7. The vial adaptor of claim 1, wherein the valve comprises silicone.

8. The vial adaptor of claim 2, wherein the anti-reflux valve is configured to resist fluid flow towards the vial when the vial adaptor is coupled to the vial.

9. The vial adaptor of claim 2, wherein the anti-reflux valve is configured to allow fluid flow towards the vial only upon deliberate user action when the vial adaptor is coupled to the vial.

10. The vial adaptor of claim 2, wherein the anti-reflux valve is configured to allow fluid flow towards the vial only while the plunger of the syringe is depressed when the vial adaptor is coupled to the vial.

11. The vial adaptor of claim 1, wherein the vial adaptor further comprises a regulator channel.

12. The vial adaptor of claim 11, wherein the vial adaptor further comprises a regulating enclosure in fluid communication with the regulator channel.

13. The vial adaptor of claim 12, wherein the regulator channel is configured to provide fluid communication between ambient air and the regulating enclosure.

14. The vial adaptor of claim 13, wherein the valve is intended to resist unintended plunger movement induced by the regulating enclosure.

18. The vial adaptor of claim 1, wherein the valve is configured to provide a single bidirectional flow path through the valve when the vial adaptor is coupled to the vial.

19. The vial adaptor of claim 18, wherein, when the plunger is at least partially withdrawn from the barrel, the medicinal fluid flows from the vial through an opening in the valve and into the barrel of the syringe.

20. The vial adaptor of claim 19, wherein, when the plunger is depressed, the medicinal fluid flows from the barrel of the syringe through the opening in the valve and into the vial.

21. The vial adaptor of claim 20, wherein the opening in the valve has a first cracking pressure and a second cracking pressure, and wherein the second cracking pressure is greater than the first cracking pressure.

22. The vial adaptor of claim 21, wherein the valve is oriented such that medicinal fluid flow away from the vial passes through the first cracking pressure and medicinal fluid flow toward the vial passes through the second cracking pressure.

23. The vial adaptor of claim 18, wherein a fluid-tight seal exists between the valve and a sidewall of the extractor channel.

24. The vial adaptor of claim 18, wherein the valve is a dome-shaped valve.

25. The vial adaptor of claim 18, wherein the valve comprises:

a cup having a base with an opening formed therein; and

a blocking structure disposed adjacent to the base of the cup, the blocking structure configured to obstruct at least a portion of the opening.

26. The vial adaptor of claim 25, wherein the blocking structure comprises a washer-shaped member.

15. A method of regulating fluid flow through a vial adaptor, the method comprising:

connecting a vial adaptor to a vial containing a medicinal fluid, wherein the vial adaptor comprises;

a medical connector interface configured to connect the vial adaptor to a syringe, wherein the syringe has a barrel and a plunger disposed within the barrel;

a piercing member;

an extractor channel at least partially defined by the piercing member;

an extractor aperture in fluid communication with the medical connector interface; and

a valve positioned within the extractor channel, the valve configured to resist unintended plunger movement;

wherein the vial adaptor is configured to place at least a portion of the extractor channel in fluid communication with the medicinal fluid contained in the vial;

wherein the extractor channel is configured to facilitate transfer of the medicinal fluid between the vial adaptor and the vial;

wherein the valve permits the medicinal fluid to flow from the syringe to the vial when the plunger is depressed;

wherein the valve permits the medicinal fluid to flow away from the vial when the plunger is withdrawn;

wherein the valve has a first cracking pressure for allowing fluid flow away from the vial and a second cracking pressure for allowing fluid flow towards the vial; and

wherein the second cracking pressure is greater than the first cracking pressure, such that the cracking pressure of the valve is greater in the direction of fluid flow towards the vial than in the direction of fluid flow away from the vial;

permitting the medicinal fluid to flow through the extractor channel from the vial to the syringe; and

impeding medicinal fluid flow from the syringe to the vial by permitting the valve to resist unintended plunger movement.

16. The method of claim 15, wherein the method further comprises permitting fluid to flow from the syringe to the vial while depressing the plunger of the syringe, such that the fluid flow has a pressure equal to or greater than the second cracking pressure.

17. A method of manufacturing a vial adaptor, the method comprising:

disposing a valve within an extractor channel of a vial adaptor, the vial adaptor comprising;

a medical connector interface configured to connect the vial adaptor to a syringe, wherein the syringe has a barrel and a plunger disposed within the barrel;

a piercing member;

the extractor channel at least partially defined by the piercing member; and

an extractor aperture in fluid communication with the medical connector interface;

wherein the vial adaptor is configured to be coupled with a vial containing a medicinal fluid, such that at least a portion of the extractor channel is in fluid communication with the medicinal fluid contained in the vial when the vial adaptor is coupled to the vial;

wherein the extractor channel is configured to facilitate transfer of the medicinal fluid between the vial adaptor and the vial when the vial adaptor is coupled to the vial;

wherein the valve is configured to resist unintended plunger movement; and

wherein the valve permits the medicinal fluid to flow from the syringe to the vial when the plunger is depressed and when the vial adaptor is coupled to the vial;

wherein the valve permits the medicinal fluid to flow away from the vial when the plunger is withdrawn;

wherein the valve has a first cracking pressure for allowing fluid flow away from the vial and a second cracking pressure for allowing fluid flow towards the vial; and

wherein the second cracking pressure is greater than the first cracking pressure, such that the cracking pressure of the valve is greater in the direction of fluid flow towards the vial than in the direction of fluid flow away from the vial.