Pressure-regulating vial adaptors and methods

• US 9,987,195 B2
• Filed: 06/17/2014
• Issued: 06/05/2018
• Est. Priority Date: 01/13/2012
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): SU, SUSAN SHAN
• Application Number:
  US14/307,320
• Publication Number:
  US 20150011963A1
• Time in Patent Office: 1,449 Days
• Field of Search: 604411-414
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/1493 Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2075 for external venting
• 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 member, a connector configured to couple the adaptor with a vial, a regulator channel, and an extractor channel formed in the housing member. The extractor 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 flow of a regulating fluid to compensate for changes in volume of a medical fluid in the vial. In some embodiments, an expansion member is disposed on the housing member and is configured to expand and contract in accordance with changes in the volume of a medical fluid in the vial.

Claims

1. A vial adaptor comprising:

a housing member comprising a piercing member having a proximal end and a distal end, the distal end of the piercing member configured to pierce the septum of a vial;

a connector configured to couple the housing member with the vial;

an extractor channel formed in the housing member, the extractor channel configured to facilitate withdrawal of a medical fluid from the vial when the adaptor is coupled to the vial;

a regulator channel formed in the piercing member, the regulator channel configured to facilitate a flow of a regulating fluid therethrough during withdrawal of the medical fluid; and

an expansion member connected with an external surface of the proximal end of the piercing member and in fluid communication with the regulator channel, the expansion member configured to contact the septum during insertion of the piercing member into the vial and to expand to receive the flow of the regulating fluid as the medical fluid is withdrawn from the vial.

2. The vial adaptor of claim 1, wherein the expansion member is configured to regulate pressure in the vial when fluid is withdrawn from the vial.

3. The vial adaptor of claim 1, wherein the piercing member comprises a terminal member.

4. The vial adaptor of claim 3, wherein the terminal member is detachable from a remainder of the piercing member.

5. The vial adaptor of claim 3, wherein the terminal member comprises brass or aluminum.

6. The vial adaptor of claim 3, wherein the terminal member comprises polypropelene, polycarbonate, or glass impregnated polybutylene terephthalate.

7. The vial adaptor of claim 3, wherein the terminal member is in airtight engagement with the expansion member.

8. The vial adaptor of claim 1, wherein the expansion member comprises polyisoprene or silicone rubber.

9. The vial adaptor of claim 1, wherein the piercing member is configured to have a total axial length that is about equal to a total axial length of the vial.

10. The vial adaptor of claim 1, wherein a distal-most end of the piercing member is configured to be positioned adjacent a distal end of the vial.

11. The vial adaptor of claim 1, wherein a distal end of the piercing member is closed.

12. The vial adaptor of claim 1, wherein the piercing member comprises a vent in fluid communication with the regulator channel.

13. The vial adaptor of claim 1, wherein the piercing member comprises a plurality of perforations in fluid communication with the regulator channel.

14. The vial adaptor of claim 1, wherein the piercing member comprises a plurality of annular ribs.

15. The vial adaptor of claim 1, further comprising a lubricant applied to at least one of the piercing member and the expansion member.

16. The vial adaptor of claim 15, wherein the lubricant comprises fluorosilicone oil.

17. The vial adaptor of claim 1, wherein the expansion member is bonded to the piercing member with an adhesive.

18. The vial adaptor of claim 17, wherein the adhesive comprises a RTV silicone adhesive.

19. The vial adaptor of claim 1, wherein the expansion member is connected with a proximal-most end of the piercing member.

20. The vial adaptor of claim 1, wherein the expansion member is connected with the piercing member a distance from a proximal-most end of the piercing member.

21. The vial adaptor of claim 20, wherein the distance is about 10% of an axial length of the piercing member.

22. The vial adaptor of claim 1, wherein the expansion member further comprises a proximal portion that does not include a proximal-most end of the expansion member.

23. The vial adaptor of claim 1, wherein the expansion member further comprises a distal portion that does not include a distal-most end of the expansion member.

24. The vial adaptor of claim 1, wherein the external surface of the proximal end of the piercing member is positioned radially outward of the piercing member with respect to an axial center of the piercing member.

25. The vial adaptor of claim 1, wherein the expansion member further comprises at least one aperture and containing a volume, the expansion member configured to receive through the aperture and into the volume at least 25% of the axial length of the piercing member.

26. The vial adaptor of claim 25, wherein the volume comprises a generally cylindrical shape.

27. The vial adaptor of claim 25, wherein the expansion member is configured to receive at least 50% of the axial length of the piercing member.

28. The vial adaptor of claim 1, wherein the expansion member is configured to expand axially at least about 4 times as much as the expansion member expands radially.

29. The vial adaptor of claim 1, wherein the piercing member further comprises a plurality of texture elements configured to inhibit axial displacement of the expansion member during insertion of the piercing member into the vial.

30. The vial adaptor of claim 1, wherein the expansion member comprises a bag.

31. The vial adaptor of claim 1, wherein the piercing member further comprises a midpoint that is located about halfway along the longitudinal length of the piercing member, and wherein the expansion member is connected with the external surface of the proximal end of the piercing member at a location that is proximal of the midpoint.

32. The vial adaptor of claim 1, further comprising a lubricant on an exterior surface of the expansion member.

33. A method of maintaining a substantially constant pressure within a vial, the method comprising:

coupling a housing member to a vial, the housing comprising a piercing member;

piercing a septum of the vial with a distal end of the piercing member, wherein piercing the septum of the vial with the distal end of the piercing member comprises contacting the septum with an expansion member;

permitting a medical fluid to flow through an extractor channel formed in the housing member, the extractor channel configured to facilitate withdrawal of a medical fluid from the vial when the adaptor is coupled to the vial; and

permitting a regulating fluid to flow through a regulator channel during withdrawal of the medical fluid, the regulator channel formed in the piercing member, the regulating fluid being received in the expansion member, the expansion member being connected to an external surface of the piercing member at a proximal end of the piercing member, the expansion member being configured to expand as the medical fluid is withdrawn.

34. The method of claim 33, wherein the expansion member is connected to the proximal-most end of the piercing member.

35. The method of claim 33, wherein the expansion member is configured to regulate a pressure in the vial.

36. The method of claim 33, wherein the piercing member comprises a tip member.

37. The method of claim 36, wherein the tip member is detachable from remainder of the piercing member.

38. The method of claim 36, wherein the tip member comprises polypropelene, polycarbonate, or glass impregnated polybutylene terephthalate.

39. The method of claim 36, wherein the tip member is in airtight engagement with the expansion member.

40. The method of claim 33, wherein the expansion member comprises polyisoprene or silicone rubber.

41. The method of claim 33, wherein the piercing member is configured to have a total axial length that is about equal to a total axial length of the vial.

42. The method of claim 33, wherein a distal-most end of the piercing member is configured to be positioned adjacent a distal end of the vial.

43. The method of claim 33, wherein a distal end of the piercing member is closed.

44. The method of claim 33, wherein the piercing member comprises a vent in fluid communication with the regulator channel.

45. The method of claim 33, wherein the piercing member comprises a plurality of perforations in fluid communication with the regulator channel.

46. The method of claim 33, wherein the piercing member comprises a plurality of annular ribs.

47. The method of claim 33, further comprising applying a lubricant to at least one of the piercing member and the expansion member.

48. The method of claim 47, wherein the lubricant comprises fluorosilicone oil.

49. The method of claim 33, wherein the expansion member is bonded to the piercing member with an adhesive.

50. The method of claim 49, wherein the adhesive comprises a RTV silicone adhesive.

51. The method of claim 33, further comprising applying a lubricant to an exterior surface of the expansion member.

52. A vial adaptor comprising:

a housing member comprising a piercing member having a proximal end, a distal end, and a plurality of annular ribs, the distal end of the piercing member configured to pierce the septum of a vial;

a connector configured to couple the housing member with the vial;

an extractor channel formed in the housing member, the extractor channel configured to facilitate withdrawal of a medical fluid from the vial when the adaptor is coupled to the vial;

a regulator channel formed in the piercing member, the regulator channel configured to facilitate a flow of a regulating fluid therethrough during withdrawal of the medical fluid; and

an expansion member connected with an external surface of the proximal end of the piercing member and in fluid communication with the regulator channel, the expansion member configured to expand to receive the flow of the regulating fluid as the medical fluid is withdrawn from the vial.

53. The vial adaptor of claim 52, further comprising a lubricant on an exterior surface of the expansion member.

54. The vial adaptor of claim 52, wherein the expansion member is configured to expand axially at least about 4 times as much as the expansion member expands radially.

55. The vial adaptor of claim 52, wherein the piercing member further comprises a midpoint that is located about halfway along the longitudinal length of the piercing member, and wherein the expansion member is connected with the external surface of the proximal end of the piercing member at a location that is proximal of the midpoint.