Pressure-regulating vial adaptors

• US 9,610,217 B2
• Filed: 09/17/2014
• Issued: 04/04/2017
• Est. Priority Date: 03/22/2012
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): SCHMID, ANDREW C
• Application Number:
  US14/488,856
• Publication Number:
  US 20150000787A1
• Time in Patent Office: 930 Days
• Field of Search: 141 27, 141311 R, 141312, 141318, 141319, 141321, 141322, 141326, 141329, 141330, 141346, 141351-353, 141357, 141369, 141370, 141372, 141383, 141384, 141385, 141386, 604411, 604415
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2075 for external 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

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. The regulator assembly can include a valve configured to transition between a closed configuration and an opened configuration.

Claims

1. A vial adaptor having an insertion axis, the vial adaptor configured to be used in an area with a floor and configured to couple with a sealed vial, the vial adaptor comprising:

a housing assembly comprising a piercing member capable of piercing a septum of a sealed vial when the piercing member is urged against the septum of the vial;

an extractor channel, wherein the extractor channel extends between a proximal extractor aperture and a distal extractor aperture and is configured to permit withdrawal of fluid from the sealed vial when the vial adaptor is coupled to the sealed vial, and wherein at least a portion of the extractor channel passes through at least a portion of the housing assembly;

a regulator channel, wherein the regulator channel extends between a proximal regulator aperture and a distal regulator aperture, and wherein at least a portion of the regulator channel passes through at least a portion of the housing assembly; and

an occluder valve housed in the regulator channel and configured to transition between a closed configuration and an opened configuration in response to rotation of the vial adaptor about an axis of rotation between an upright position and an upside down position, wherein the proximal extractor aperture is further from the floor than the distal extractor aperture when the vial adaptor is in the upright position and the proximal extractor aperture is closer to the floor than the distal extractor aperture when the vial adaptor is in the upside down position;

wherein the occluder valve inhibits passage of fluid past the occluder valve toward the proximal regulator aperture when the occluder valve is in the closed configuration, and

wherein the axis of rotation is perpendicular to the insertion axis of the vial adaptor, such that the occluder valve consistently transitions between the closed configuration and the opened configuration in response to rotation of the vial adaptor substantially independent of the axis of rotation about which the vial adaptor is rotated.

2. The vial adaptor of claim 1, wherein occluder valve transitions to the closed configuration when the vial adaptor is rotated to the upside down position.

3. The vial adaptor of claim 1, wherein the occluder valve transitions to the opened configuration when the vial adaptor is rotated to the upright position.

4. The vial adaptor of claim 1, wherein the occluder valve comprises a valve chamber in fluid communication with the regulator channel, an occluding member within the valve chamber, and a valve seat, wherein the occluder valve is configured to transition to the closed configuration upon engagement between the occluding member and the valve seat, and wherein the occluder valve is configured to transition to the opened configuration upon disengagement of the occluding member from the valve seat.

5. The vial adaptor of claim 4, wherein the occluding member moves within the valve chamber under the influence of gravity.

6. The vial adaptor of claim 4, wherein the occluding member is a spherical ball.

7. The vial adaptor of claim 4, wherein the occluding member has a cylindrical body with a tapered end.

8. The vial adaptor of claim 4, wherein the occluding member has an ellipsoidal shape.

9. The vial adaptor of claim 1, wherein the occluder valve has a generally cylindrical shape and an axial centerline.

10. The vial adaptor of claim 9, wherein the occluder valve is rotatable about the axial centerline of the occluder valve with respect to the regulator channel.

11. The vial adaptor of claim 1, wherein the vial adaptor further comprises a filter positioned in the regulator channel between the occluder valve and the proximal regulator aperture.

12. The vial adaptor of claim 11, wherein the filter is a hydrophobic filter.

13. A vial adaptor configured to couple with a sealed vial, the vial adaptor having an insertion axis and comprising:

a housing assembly comprising a piercing member capable of piercing a septum of a sealed vial when the piercing member is urged against the septum of the vial;

an extractor channel, wherein at least a portion of the extractor channel passes through at least a portion of the housing assembly;

a regulator channel, wherein the regulator channel defines a regulator fluid flow path and extends between a proximal regulator aperture and a distal regulator aperture, and wherein at least a portion of the regulator channel passes through at least a portion of the housing assembly; and

an occluder valve located in at least a portion of the regulator channel and having a proximal opening nearest the proximal regulator aperture and a distal opening nearest the distal regulator aperture, the occluder valve further configured to transition between a closed configuration and an opened configuration, wherein the occluder valve comprises;

a valve chamber in fluid communication with the regulator channel and the regulator fluid flow path, the valve chamber having an occluding member, a movement path for the occluding member, and a valve seat;

a valve channel in fluid communication with the valve chamber and the regulator channel and the regulator fluid flow path;

a proximal interface defining the fluid boundary between the proximal opening and the regulator channel; and

a distal interface defining the fluid boundary between the distal opening and the regulator channel;

wherein the occluder valve is configured to transition to the closed configuration when the occluding member is engaged with the valve seat, the occluder valve is configured to transition to the opened configuration when the occluding member is disengaged from the valve seat, and wherein an angle formed between the movement path for the occluding member and the regulator fluid flow path at one or more of the proximal interface and the distal interface is oblique or perpendicular.

14. The vial adaptor of claim 13, wherein the movement path for the occluding member is oblique or perpendicular to an installation path of the occluder valve.

15. The vial adaptor of claim 14, wherein the angle formed between the movement path and the installation path is greater than about 45°

and less than about 135°

.

16. The vial adaptor of claim 13, wherein the occluding member is a spherical ball.

17. The vial adaptor of claim 13, wherein the occluding member has a cylindrical body with one tapered end.

18. The vial adaptor of claim 13, wherein the occluding member has an ellipsoidal shape.

19. The vial adaptor of claim 15, wherein the angle formed between the movement path and the installation path is about 90°

.

20. The vial adaptor of claim 13, wherein the angle formed between the movement path and the installation path is substantially the same as the angle formed between the insertion axis of the vial adaptor and the installation path.

21. The vial adaptor of claim 13, wherein the movement path is substantially parallel to the insertion axis of the vial adaptor.

22. The vial adaptor of claim 13, wherein the vial adaptor further comprises a filter in the regulator channel between the occluder valve and the proximal regulator aperture.

23. The vial adaptor of claim 22, wherein the filter is a hydrophobic filter.