VIAL ADAPTORS AND METHODS FOR REGULATING PRESSURE

• US 20100049159A1
• Filed: 10/27/2009
• Published: 02/25/2010
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Granted Patent: US 8,267,913 B2
• Time in Patent Office: Days
• US Class Current: 604/411
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2079 Filtering means
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61J 2200/76 for fluid level
• CPC Class Codes: Y10T 137/0402 Cleaning, repairing, or assembling
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

In certain embodiments, a vial adaptor for removing liquid contents from a vial comprises a piercing member and a bag. The bag can be contained within the piercing member such that the bag is introduced to the vial when the vial adaptor is coupled with the vial. In some embodiments, the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial. In other embodiments, a vial comprises a bag for regulating pressure within the vial as liquid is removed therefrom. In some embodiments, a vial adaptor is coupled with the vial in order to remove the liquid. In some embodiments, as the liquid is removed from the vial via the adaptor, the bag expands within the vial, and in other embodiments, the bag contracts within the vial.

Claims

11. A method of regulating pressure in a closed vial containing medicinal fluid, the method comprising:

inserting a piercing member extending from a vial adaptor into the closed vial;

securing the vial adaptor to the closed vial;

withdrawing medicinal fluid from the vial through an extractor channel formed in the vial adaptor;

regulating pressure in the closed vial by permitting a bag at least partially housed within the piercing member to expand while medicinal fluid is withdrawn from the vial.

1. A method of withdrawing fluid from a closed vial containing medicinal fluid, the method comprising:

providing a pressure regulating adaptor for coupling with the closed vial and removing fluid therefrom, the adaptor comprising;

a piercing member configured to be inserted in the vial;

a cap connector configured to secure the adaptor to the vial; and

a bag at least partially housed within the piercing member such that at least a portion of the bag is within the vial when the piercing member is in the vial;

coupling the pressure regulating adaptor to the closed vial such that the piercing member is inserted at least partially into the vial; and

withdrawing medicinal fluid from the vial.

2. The method of claim 1, wherein the bag is configured to move from a first position at least partially housed within the piercing member to a second position at least partially outside of the piercing member when medicinal fluid is withdrawn from the vial.

3. The method of claim 2, wherein the bag is configured to automatically move from the first to the second position upon withdrawal of fluid from the vial.

4. The method of claim 1, wherein the bag is entirely housed within the piercing member before insertion of the piercing member into the vial.

5. The method of claim 1, wherein the piercing member is pointed.

6. The method of claim 1, wherein the adaptor comprises a regulator channel in fluid communication with an interior of the bag.

7. The method of claim 6, wherein the regulator channel is configured to fluidly communicate with an environment exterior to the vial when the adaptor is coupled with the vial.

8. The method of claim 6, wherein the bag is configured to automatically expand as fluid is removed from the vial and as air flows into the bag via the regulator channel, thereby equalizing pressure within the vial.

9. The method of claim 6, wherein the regulator channel is in fluid communication with a filter.

10. The method of claim 9, wherein the filter is configured to permit passage of air therethrough and substantially prevent passage of liquid therethrough.

12. The method of claim 11, wherein the piercing member defines an opening in fluid communication with the extractor channel.

13. The method of claim 11, wherein securing the vial adaptor comprises snapping a skirt extending from the vial adaptor over the closed vial.

14. The method of claim 11, wherein the piercing member comprises a tip configured to pierce a portion of the vial to allow at least a portion of the piercing member to be advanced into the vial.

15. The method of claim 14, wherein the tip is configured to separate from the adaptor to allow the bag to expand within the vial.

17. The method of claim 11, further comprising coupling a syringe to the vial adaptor.

18. The method of claim 17, wherein the syringe is in fluid communication with the extractor channel when the syringe is coupled to the vial adaptor.

19. The method of claim 17, wherein the vial adaptor is configured to seal upon decoupling of the syringe therefrom.

15-1. The method of claim 14, wherein the tip includes a stem, the bag engaging the stem prior to insertion of the piercing member into the vial.

20. A method of manufacturing a pressure-regulating vial adaptor, the method comprising:

providing a piercing member extending from a cap connector configured to secure a vial adaptor to a vial; and

inserting a bag into the piercing member such that at least a portion of the bag is within the vial when the piercing member is in the vial, the bag configured to expand in response to pressure changes.

21. The method of claim 20, wherein the bag is configured to move between a stored position, in which the bag is housed at least partially within the piercing member, and a deployed position, in which at last a portion of the bag is expanded within the vial.

22. The method of claim 20, wherein the piercing member comprises a regulator channel configured to channel air from an environment exterior to the vial into the bag.