Devices and methods for transferring fluid to or from a vial

• US 10,327,989 B2
• Filed: 05/05/2017
• Issued: 06/25/2019
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US15/588,380
• Publication Number:
  US 20170239140A1
• Time in Patent Office: 781 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 system capable of transferring medicinal fluid to or from a vial, the system comprising:

a cap connector configured to couple at least a portion of the system with the vial;

a medical connector interface configured to couple at least a portion of the system with an exchange device;

a piercing member configured to be inserted into the vial; and

an extractor comprising;

an extractor aperture on the piercing member;

an extractor channel configured to allow the medicinal fluid to flow between the extractor aperture and the medical connector interface; and

a groove disposed along a sidewall of the piercing member, wherein the groove has an elongate dimension extending from the extractor aperture;

wherein the extractor aperture and the groove are configured to permit medicinal fluid to enter the extractor channel; and

wherein the extractor aperture has a width that is different than a width of at least a portion of the groove.

2. The system of claim 1, wherein the groove extends distally from the extractor aperture.

3. The system of claim 1, wherein a housing portion comprises the cap connector and the medical connector interface.

4. The system of claim 3, wherein the housing portion further comprises a regulator aperture configured to permit air to pass therethrough as medicinal fluid is withdrawn from the vial, thereby equalizing a pressure difference between an interior of the vial and another environment.

5. The system of claim 1, further comprising a regulator configured to regulate pressure within the vial.

6. The system of claim 5, wherein the regulator comprises a regulator channel configured to allow gas to flow between a regulator aperture and a reservoir.

7. The system of claim 5, wherein at least a portion of the extractor and at least a portion the regulator are separate units.

8. The system of claim 1, wherein the extractor is configured to permit substantially all of the medicinal fluid from the vial to flow to the exchange device.

9. The system of claim 1, wherein the extractor aperture is positioned near the septum when at least a portion of the system is coupled with the vial, such that the system is capable of removing the medicinal fluid from the vial such that no more than a minimal amount of medicinal fluid remains in the vial.

10. The system of claim 1, wherein the system is capable of leaving no more than a minimal amount of medicinal fluid in the vial.

11. The system of claim 1, wherein a sum of a length of the groove and a width of the extractor aperture is between 0.17 inches and 0.41 inches.

12. The system of claim 1, wherein a sum of a length of the groove and a width of the extractor aperture is between 0.23 inches and 0.35 inches.

13. The system of claim 1, wherein a length of the groove is between 0.15 inches and 0.35 inches.

14. The system of claim 1, wherein a length of the groove is between 0.20 inches and 0.30 inches.

15. The system of claim 1, wherein a width of the groove is between 0.010 inches and 0.030 inches.

16. The system of claim 1, wherein a width of the extractor aperture is between 0.020 inches and 0.060 inches.

17. The system of claim 1, wherein a depth of the groove is between 0.020 inches and 0.040 inches.

18. The system of claim 1, wherein a depth of the groove is between 0.025 inches and 0.35 inches.

19. The system of claim 1, wherein an edge of at least one of the extractor aperture and the groove is angled sufficiently sharply to prevent the septum from completely conforming to the shape of the extractor aperture and groove.

20. The system of claim 1, wherein a depth of at least one of the extractor aperture and the groove is sufficiently large to prevent the septum from completely conforming to the shape of the extractor aperture and groove.

21. The system of claim 1, wherein a first portion of the groove has a first width and a second portion of the groove has a second width, wherein the first width and the second width are not the same.

22. The system of claim 1, wherein a depth dimension of the groove follows a chord offset from a central axis of the piercing member.

23. The system of claim 1, wherein the extractor is configured to permit medicinal fluid to flow through the extractor when the extractor aperture or groove is partially obstructed by a septum of the vial.

24. A system capable of removing medicinal fluid from a vial, the system comprising:

a cap connector configured to couple at least a portion of the system with the vial;

a piercing member configured to be inserted into the vial;

a medical connector interface configured to couple at least a portion of the system with an exchange device; and

an extractor comprising;

an extractor aperture on the piercing member; and

a groove extending from the extractor aperture and disposed along a sidewall of the piercing member,

wherein the extractor aperture and the groove are positioned and configured such that the system is capable of removing medicinal fluid from two or more different vials,

wherein the two or more different vials vary by size, by cap dimensions, or by size and cap dimensions.

25. The system of claim 24, wherein the extractor comprises a groove having an elongate dimension extending from the extractor aperture, such that the extractor is configured to permit medicinal fluid to enter an extractor channel extending between the extractor aperture and the medical connector interface even when at least one of the extractor aperture and groove is partially obstructed by a septum of the vial.

26. The system of claim 24, wherein at least one of the extractor aperture and the groove extends along a length of the piercing member.

27. The system of claim 24, wherein at least one of the extractor aperture and the groove extends at an angle with respect to a length of the piercing member.

28. The system of claim 24, wherein the groove is straight.

29. The system of claim 24, wherein the groove is curved.

30. The system of claim 24, wherein the extractor is configured such that at least a portion of at least one of the extractor aperture and groove can extend past a lower surface of the septum when the piercing member is inserted into the vial.

31. The system of claim 24, wherein at least a portion of the extractor aperture extends into the piercing member at an angle, such that a first portion of the extractor aperture has a first depth and a second portion of the extractor aperture has a second depth, wherein the first depth and the second depth are not the same.

32. The system of claim 24, wherein at least a portion of the groove extends into the piercing member at an angle, such that a first portion of the groove has a first depth and a second portion of the groove has a second depth, wherein the first depth and the second depth are not the same.

33. The system of claim 24, wherein the extractor aperture and groove are configured such that a fluid passageway remains between the septum and a volume of at least one of the extractor aperture and the groove that is not filled in by the septum when at least a portion of the system is coupled with the vial.

34. A method of withdrawing medicinal fluid from a vial, the method comprising:

coupling to the vial a system for transferring medicinal fluid between the vial and an exchange device, wherein the system comprises;

a cap connector configured to couple at least a portion of the system with the vial;

a medical connector interface configured to couple at least a portion of the system with the exchange device;

a piercing member configured to be inserted into the vial; and

an extractor comprising;

an extractor aperture on the piercing member;

an extractor channel configured to allow the medicinal fluid to flow between the extractor aperture and the medical connector interface; and

a groove disposed along a sidewall of the piercing member, wherein the groove has an elongate dimension extending from the extractor aperture;

wherein the extractor aperture and the groove are configured to permit medicinal fluid to enter the extractor channel; and

wherein the extractor aperture has a width that is different than a width of at least a portion of the groove;

and

removing the medicinal fluid until no more than a minimal amount of medicinal fluid remains in the vial.

35. The method of claim 34, wherein the groove extends from the extractor aperture, and wherein the groove is configured to provide a fluid passageway to the extractor channel even when the extractor aperture is partially or completely obstructed by a septum of the vial.

36. The method of claim 34, wherein removing medicinal fluid comprises removing all of the medicinal fluid from the vial.

37. The method of claim 34, wherein a housing portion comprises the cap connector and the medical connector interface.

38. The method of claim 37, wherein the housing portion further comprises a regulator aperture configured to permit air to pass therethrough as medicinal fluid is withdrawn from the vial, thereby equalizing a pressure difference between an interior of the vial and another environment.

39. The method of claim 34, wherein the exchange device is capable of withdrawing medicinal fluid from the vial, such that substantially the entire volume of medicinal fluid is transferred from the vial to the exchange device.

40. The method of claim 34, wherein the extractor aperture and groove are positioned and configured such that the system is capable of removing medicinal fluid from two or more different vials, wherein the two or more different vials vary by size, by cap dimensions, or by size and cap dimensions.