Devices and methods for transferring medicinal fluid to or from a container

• US 9,993,391 B2
• Filed: 11/04/2015
• Issued: 06/12/2018
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Warren, Dee E., Lopez, Dan
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/932,813
• Publication Number:
  US 20160120754A1
• Time in Patent Office: 951 Days
• 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

1. A closed medical fluid transfer system capable of transferring medical fluid to and from a medical vial with a septum while automatically equalizing pressure within the medical vial to resist the escape of medical fluid from the medical vial into a surrounding environment, the closed medical fluid transfer system comprising:

a vial adaptor with a connector portion and a piercing member, the connector portion comprising a central portion and one or more projections distally extending from the central portion, the connector portion being configured to secure the vial adaptor to the medical vial, and the piercing member being stationary with respect to the central portion of the connector portion;

a syringe that is separate from and configured to be positioned in fluid communication with the vial adaptor, the syringe being configured to introduce liquid into and to extract liquid from the medical vial by way of the vial adaptor; and

a variable volume of sterilized gas positioned within a rigid enclosure, the variable volume of sterilized gas being configured to regulate the pressure within the medical vial by constantly decreasing and increasing a volume of gas in the medical vial during use to compensate for a volume of liquid that is introduced into and extracted from the medical vial, the variable volume of sterilized gas being configured to remain sterile and contained within the rigid enclosure until the variable volume of sterilized gas is placed in fluid communication with an interior of the medical vial by way of the vial adaptor.

2. A combination of the medical fluid transfer system of claim 1 and the medical vial.

3. The medical fluid transfer system of claim 1, wherein the pressure within the medical vial is constant during use of the medical fluid transfer system.

4. The medical fluid transfer system of claim 1, wherein the pressure within the medical vial varies by no more than about 1 psi during use of the medical fluid transfer system.

5. The medical fluid transfer system of claim 1, wherein the variable volume of sterilized gas is initially retained within the rigid enclosure by a cover.

6. The medical fluid transfer system of claim 5, wherein the cover is removable.

7. The medical fluid transfer system of claim 1, wherein the variable volume of sterilized gas is contained within a reservoir within the rigid enclosure.

8. The medical fluid transfer system of claim 7, wherein the reservoir is a flexible reservoir.

9. The medical fluid transfer system of claim 1, wherein the rigid enclosure is part of the vial adaptor.

10. The medical fluid transfer system of claim 1, wherein a hydrophobic contaminant filter is positioned in between an opening on the piercing member and the variable volume of sterilized gas.

11. The medical fluid transfer system of claim 1, further comprising a medical connector that does not require an exposed needle to transfer medical fluid.

12. The medical fluid transfer system of claim 1, wherein the variable volume of sterilized gas within the rigid enclosure that is capable of being transferred to the medical vial while regulating the pressure within the medical vial is at least as great as a volume of medical fluid inside of the medical vial.

13. A medical fluid transfer system for use with a medical vial having a septum and containing medical fluid, the medical fluid transfer system comprising:

a vial adaptor with a piercing member and a central portion, the vial adaptor being configured to securely attach to the medical vial, the piercing member being configured to pierce the septum of the medical vial at the same time that the central portion is positioned proximate to the septum on the medical vial;

a volume of sterilized gas positioned within a rigid enclosure, a portion of the volume of sterilized gas being configured to move within the medical fluid transfer system to automatically maintain a pressure within the medical vial substantially constant while transferring the medical fluid to and from the medical vial by decreasing and increasing a volume of gas in the medical vial as medical fluid is introduced into and extracted from the medical vial;

wherein the volume of sterilized gas is configured to remain sterile and contained within the rigid enclosure until the volume of sterilized gas is placed in fluid communication with the medical vial.

14. The medical fluid transfer system of claim 13, wherein the volume of sterilized gas is not exposed to ambient gas at any stage in the use of the medical fluid transfer system.

15. The medical fluid transfer system of claim 13, wherein maintaining the pressure in the medical vial resists the escape of medical fluid from the medical vial into a surrounding environment.

16. The medical fluid transfer system of claim 13, wherein the pressure within the medical vial is maintained within 2 psi.

17. The medical fluid transfer system of claim 13, wherein the pressure within the medical vial is constant during use.

18. The medical fluid transfer system of claim 13, wherein a hydrophobic contaminant filter is positioned in between an opening on the piercing member and the volume of sterilized gas.

19. A pressure-regulating medical-fluid transfer system configured to connect with a vial that contains a volume of medical fluid and is sealed with a septum, the pressure-regulating medical-fluid transfer system comprising:

a vial adaptor comprising an upper side and a lower side;

a vial connector extending distally from the lower side of the vial adaptor, the vial connector being configured to connect with the vial;

a piercing member extending distally from the lower side of the vial adaptor and fixed in relation to the vial connector, the piercing member comprising a first portion of an extractor channel that is configured to convey medical fluid to and from the vial, the extractor channel being configured to be sealed before and after the extractor channel is accessed by a syringe that is separate from the vial adaptor without requiring an exposed needle;

a medical connector interface comprising an elongate tube that extends proximally from the upper side of the vial adaptor, the elongate tube comprising a second portion of the extractor channel;

a hydrophobic contaminant filter configured to filter gas within the medical-fluid transfer system;

a regulator channel in communication with an enclosure that is configured to automatically increase or decrease in volume with corresponding changes in the volume of medical fluid in the vial; and

a distal extractor aperture in communication with the extractor channel and a distal regulator aperture in communication with the regulator channel, the distal regulator aperture being more distal than the distal extractor aperture.

20. A combination of the medical-fluid transfer system of claim 19 and the vial.

21. A combination of the medical fluid transfer system of claim 19 and the syringe.

22. The medical-fluid transfer system of claim 21, wherein the enclosure contains an initial volume of regulating fluid that is equal to or greater than a volume capable of holding medical fluid in the vial.

23. The medical-fluid transfer system of claim 22, wherein the enclosure contains sterilized gas.

24. The medical-fluid transfer system of claim 23, wherein the sterilized gas is configured to remain sterile and contained in the enclosure up through coupling of the medical-fluid transfer system with the vial.

25. The medical-fluid transfer system of claim 19, wherein the enclosure comprises a flexible bag.

26. The medical-fluid transfer system of claim 25, wherein the enclosure is positioned within a rigid casing.