Pressure-regulating vial adaptors and methods

• US 9,993,390 B2
• Filed: 03/27/2015
• Issued: 06/12/2018
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Seifert, John M., Fangrow, Thomas F.
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US14/671,827
• Publication Number:
  US 20150202121A1
• Time in Patent Office: 1,173 Days
• Field of Search: 604403, 604405, 604411, 604414, 604415
• 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 vial adaptor comprising:

a regulator channel;

a regulating enclosure portion capable of fluid communication with the regulator channel, wherein the regulating enclosure portion is configured to move between a first orientation in which at least a portion of the regulating enclosure portion is at least partially unexpanded or folded and a second orientation in which at least a portion of the regulating enclosure portion is at least partially expanded or unfolded as a result of fluid being withdrawn from the vial;

an input port capable of fluid communication with the regulator channel and configured to permit ambient air to enter the regulator channel;

a medical connector interface configured to couple the adaptor with a medical device;

a filter capable of preventing contaminants from entering the vial;

wherein a distal portion of the regulator channel and a portion of an extractor channel are configured to be inserted into the vial; and

a one-way valve inhibiting fluid communication from the regulator channel to ambient, wherein the one-way valve is configured to permit gas that has passed through the filter to pass into the regulator channel and to inhibit gas or liquid from passing through the valve in the other direction.

2. The vial adaptor of claim 1, further comprising a cap connector at least partially surrounding the piercing member, the cap connector having at least one projection configured to couple the adaptor with the vial such that the piercing member accesses an interior of the vial.

3. The vial adaptor of claim 1, further comprising at least one hydrophobic filter.

4. The vial adaptor of claim 3, wherein the at least one hydrophobic filter is in communication with the regulator channel and the input port.

5. The vial adaptor of claim 3, wherein the at least one hydrophobic filter is in communication with the regulating enclosure portion.

6. The vial adaptor of claim 1, wherein regulating enclosure portion is at ambient pressure in the second orientation.

7. The vial adaptor of claim 1, wherein the regulating enclosure portion is at greater than ambient pressure in the second orientation.

8. The vial adaptor of claim 1, wherein the regulator channel is configured to permit ambient air to flow into the regulator channel as fluid is withdrawn from the vial, thereby equalizing pressure within the vial.

9. The vial adaptor of claim 1, wherein the regulating enclosure portion is constructed from a material system comprising a flexible material and a rigid material.

10. A pressure regulating adaptor for coupling with a vial, the adaptor comprising:

a regulator channel, the regulator channel configured to permit fluid to pass from an interior of the vial to the regulator channel and permit fluid to pass from the regulator channel to the interior of the vial;

wherein a distal portion of the regulator channel and a portion of an extractor channel are configured to be inserted into the vial;

a medical connector configured to couple the adaptor with a medical device that is in fluid communication with the extractor channel upon coupling of the medical device to the medical connector;

an input port configured to permit ambient air to pass into the regulator channel and substantially prevent fluid from passing to ambient;

a regulating enclosure portion configured to change in volume as a result of fluid being added to the vial, wherein the regulating enclosure portion is configured to regulate pressure in the vial as fluid is added to or withdrawn from the vial;

a filter capable of preventing contaminants from entering the vial; and

a one-way valve inhibiting fluid communication from the regulator channel to ambient, wherein the one-way valve is configured to permit gas that has passed through the filter to pass into the regulator channel and to inhibit gas or liquid from passing through the valve in the other direction.

11. The vial adaptor of claim 10, further comprising a cap connector at least partially surrounding the piercing member, the cap connector having at least one projection configured to couple the adaptor with the vial such that the piercing member accesses an interior of the vial.

12. The vial adaptor of claim 10, further comprising a one-way valve positioned between the regulator channel and ambient.

13. The vial adaptor of claim 10, further comprising at least one hydrophobic filter.

14. The vial adaptor of claim 13, wherein the at least one hydrophobic filter is in communication with both the regulator channel and the input port.

15. The vial adaptor of claim 14, wherein the at least one hydrophobic filter is in communication with the regulating enclosure portion.

16. The vial adaptor of claim 10, wherein the regulating enclosure portion is configured to automatically increase or decrease in size as fluid is added to or withdrawn from the vial.

17. A method of manufacturing a pressure regulating adaptor for coupling with a vial, the method comprising:

assembling a pressure regulating adaptor comprising;

a regulator channel;

a regulating enclosure portion capable of fluid communication with the regulator channel, wherein the regulating enclosure portion is configured to move between a first orientation in which at least a portion of the regulating enclosure portion is at least partially unexpanded or folded and a second orientation in which at least a portion of the regulating enclosure portion is at least partially expanded or unfolded as a result of medical fluid being withdrawn from the vial;

an input port in fluid communication with the regulator channel;

a medical connector interface configured to couple the adaptor with a medical device; and

a filter capable of preventing contaminants from entering the vial;

wherein at least a distal portion of the regulator channel and a portion of an extractor channel are configured to be inserted into the vial; and

connecting a one-way valve to the input port of the pressure regulating adaptor, wherein the one-way valve is configured to inhibit fluid communication from the regulator channel to ambient, and wherein the one-way valve permits ambient air that has passed through the filter to flow into the regulator channel and substantially prevents fluid from flowing out of the regulator channel to ambient.

18. The method of claim 17, further comprising connecting a filter to the input port, such that the filter filters ambient air entering the regulator channel via the input port.

19. The method of claim 17, further comprising connecting a flexible material in substantially airtight engagement with a rigid portion of the regulating enclosure portion.