Fluid transfer assembly for pharmaceutical delivery system and method for using same

• US 20070078428A1
• Filed: 08/05/2005
• Published: 04/05/2007
• Est. Priority Date: 01/22/2003
• Status: Active Grant

• Current Assignee: Duoject Medical Systems, Inc
• Original Assignee: Duoject Medical Systems, Inc
• Inventors: Reynolds, David, MacDonald, Daniel, Trepanier, Julie
• Granted Patent: US 7,678,333 B2
• Time in Patent Office: Days
• US Class Current: 604/411
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

The present invention provides a transfer assembly for transferring a fluid between a vessel and a vial and a method for using same. The vial may be a maximum recovery vial. The vessel has a body with an open end and a slidable piston positioned within the body through the open end. The maximum recovery vial has an inner chamber with an open end and a closed end and a penetrable seal covering the open end of the inner chamber. The transfer assembly includes a housing having first and second open ends and a bore extending between the first and second open ends. The housing is connectable to the piston. The transfer assembly also includes a conduit having first and second ends and first and second apertures adjacent to the first and second ends, respectively. The conduit is longitudinally slidable within the bore between a retracted position in which the first aperture is positioned within at least one of the housing and the piston when the housing is connected to the piston, and an activated position in which the first aperture protrudes through the piston into the body of the vessel when the housing is connected to the piston. The transfer assembly also includes a vial socket assembly having a vial socket and a hollow piercing member. The vial socket is sized and shaped for receiving and engaging at least a portion of the maximum recovery vial including the penetrable seal. The hollow piercing member has a first open end in fluid communication with the conduit and a second open end for piercing the penetrable seal of the maximum recovery vial. The hollow piercing member is sized to extend substantially the full length of the inner chamber of the maximum recovery vial when the maximum recovery vial is fully engaged in the vial socket. The vial socket assembly is moveable longitudinally relative to the housing in concert with the conduit.

Claims

1. A transfer assembly for transferring a fluid between a vessel and a vial, the vessel having a body with an open end and a slidable piston positioned within the body through the open end, the vial having an inner chamber with an open end and a closed end and a penetrable seal covering the open end of the inner chamber, the closed end tapering toward an apex, the transfer assembly comprising:

a housing having first and second open ends and a bore extending between the first and second open ends, the housing being connectable to the piston;

a conduit having first and second ends and first and second apertures adjacent to the first and second ends, respectively, the conduit being longitudinally slidable within the bore between a retracted position in which the first aperture is positioned within at least one of the housing and the piston when the housing is connected to the piston, and an activated position in which the first end of the conduit protrudes through the piston so that the first aperture is in fluid communication with a chamber of the vessel when the housing is connected to the piston;

a vial socket assembly having a vial socket and a hollow piercing member, the vial socket being sized and shaped for receiving and engaging at least a portion of the vial including the penetrable seal, the hollow piercing member having a first open end in fluid communication with the conduit and a second open end for piercing the penetrable seal, the hollow piercing member being sized to extend substantially the full length of the inner chamber of the vial so that the second open end of the hollow piercing member is positioned adjacent the apex of the closed end of the inner chamber when the vial is fully engaged in the vial socket, the vial socket assembly being moveable longitudinally relative to the housing in concert with the conduit so that moving the vial socket assembly longitudinally towards the housing advances the conduit from the retracted position to the activated position to fluidly connect the chamber of the vessel and the inner chamber of the vial.

2. A transfer assembly according to claim 1, wherein the vial socket has an outer wall of sufficient length to substantially overlie an outer wall of the vial when the vial is fully engaged within the vial socket.

3. A transfer assembly according to claim 1, wherein the vial socket includes a radially extending flange to assist insertion of the vial into the vial socket.

4. A transfer assembly according to claim 1, wherein the vial socket includes retaining means for retaining the vial in the vial socket when the vial is fully engaged within the vial socket.

5. A transfer assembly according to claim 1, wherein the first end of the conduit has a piercing member and the first aperture is an opening adjacent to a tip of the piercing member.

6. A transfer assembly according to claim 1, wherein the second end of the conduit is connected to a hub and the second aperture is an opening in the hub and the first open end of the hollow piercing member is connected to a post that is releasably receivable within the hub.

7. A transfer assembly according to claim 6, wherein the hub is a female luer slip and the post is a male luer slip that is releasably receivable in the female luer slip.

8. A transfer assembly according to claim 7, wherein the bore of the housing has a first portion, a second portion adjacent to the first portion, and a shoulder formed between the first and second portions, and wherein the transfer assembly further comprises a resilient biasing member positioned between the shoulder and the hub to bias the conduit into the retracted position.

9. A transfer assembly according to claim 8, wherein the resilient biasing member is a spring.

10. A transfer assembly according to claim 1, wherein the first end of the conduit has a blunt end and the first aperture is an opening on a sidewall of the conduit.

11. A transfer assembly according to claim 10, wherein the second end of the conduit is integrally connected to the vial socket assembly.

12. A system for transferring a fluid between a vessel and a vial, the system comprising:

a vessel having a body defining a chamber with an open end, the vessel having a slidable piston positioned within the body through the open end;

a vial having an inner chamber with an open end and a closed end and a penetrable seal covering the open end of the inner chamber, the closed end tapering inwardly toward an apex;

a transfer assembly including;

a housing having first and second open ends and a bore extending between the first and second open ends, the housing being connectable to the piston;

a conduit having first and second ends and first and second apertures adjacent to the first and second ends, respectively, the conduit being longitudinally slidable within the bore between a retracted position in which the first aperture is positioned within at least one of the housing and the piston when the housing is connected to the piston, and an activated position in which the first end of the conduit protrudes through the piston so that the first aperture is in fluid communication with the chamber of the vessel when the housing is connected to the piston; and

a vial socket assembly having a vial socket and a hollow piercing member, the vial socket being sized and shaped for receiving and engaging at least a portion of the vial including the penetrable seal, the hollow piercing member having a first open end in fluid communication with the conduit and a second open end for piercing the penetrable seal, the hollow piercing member being sized to extend substantially the full length of the inner chamber so that the second open end of the hollow piercing member is positioned adjacent the apex of the closed end of the inner chamber when the vial is fully engaged in the vial socket, the vial socket assembly being moveable longitudinally relative to the housing in concert with the conduit so that moving the vial socket assembly longitudinally towards the housing advances the conduit from the retracted position to the activated position to fluidly connect the chamber of the vessel and the inner chamber of the vial.

13. A system according to claim 12, wherein the vial socket is structured to inhibit removal of the vial from the vial socket once the vial is fully engaged within the vial socket.

14. A system according to claim 12, wherein the vial socket includes a radially extending flange to assist insertion of the maximum recovery vial into the vial socket.

15. A system according to claim 12, wherein the vial socket includes retaining means for retaining the vial in the vial socket when the vial is fully engaged within the vial socket.

16. A system according to claim 12, wherein the inner chamber of the vial is sized to contain a volume of fluid up to about 500 μ

L.

17. A system according to claim 12, wherein the first end of the conduit has a piercing member and the first aperture is an opening adjacent to a tip of the piercing member.

18. A system according to claim 17, wherein the second end of the conduit is connected to a hub and the second aperture is an opening in the hub and the first open end of the hollow piercing member is connected to a post that is releasably receivable within the hub.

19. A system according to claim 18, wherein the hub is a female luer slip and the post is a male luer slip that is releasably receivable in the female luer slip.

20. A system according to claim 19, wherein the bore of the housing has a first portion, a second portion adjacent to the first portion, and a shoulder formed between the first and second portions, and wherein the transfer assembly further comprises a resilient biasing member positioned between the shoulder and the hub to bias the conduit into the retracted position.

21. A system according to claim 20, wherein the resilient biasing member is a spring.

22. A system according to claim 12, wherein the first end of the conduit has a blunt end and the first aperture is an opening on a sidewall of the conduit.

23. A system according to claim 22, wherein the second end of the conduit is integrally connected to the vial socket assembly.

24. A system according to claim 12, wherein the vessel is a syringe having a neck with a needle mount for removably mounting a needle thereon and a flange adjacent the open end, the system further comprising a piston backstop positioned adjacent the flange, the piston backstop having retaining means for retaining the housing in spaced relation from the piston.

25. A system according to claim 24, further comprising a sheath assembly positioned over the neck of the syringe, the sheath assembly being connectable to the piston backstop.

26. A system according to claim 24, wherein the syringe is plastic and the piston backstop is integrally molded with the syringe.

27. A system according to claim 12, wherein the vessel is a cartridge having a neck with a penetrable closure and a cap to retain the penetrable closure thereon.

28. A system according to claim 27, further comprising a sheath assembly positioned over the neck of the cartridge and a piston backstop connectable to the sheath assembly, the piston backstop having a retaining member for retaining the housing in spaced relation from the piston.

29. A system according to claim 27, wherein the cartridge is plastic and a piston backstop is integrally molded with the cartridge, the piston backstop having a retaining member for retaining the housing in spaced relation from the piston.

30. A method for transferring a fluid between a vessel and a vial, the method comprising the steps of:

a) providing a vessel having a body defining a chamber with an open end, the vessel having a slidable piston positioned within the body through the open end;

b) providing a vial having an inner chamber with an open end and a closed end and a penetrable seal covering the open end of the inner chamber, the closed end tapering inwardly toward an apex;

c) providing a transfer assembly including;

i) a housing having first and second open ends and a bore extending between the first and second open ends;

ii) a conduit having first and second ends and first and second apertures adjacent to the first and second ends, respectively, the conduit longitudinally slidable within the bore between a retracted position in which the first end of the conduit is positioned within at least one of the housing and the piston and an activated position in which the first end of the conduit protrudes through the piston into the chamber of the vessel; and

iii) a vial socket assembly having a vial socket and a hollow piercing member, the vial socket being sized and shaped for receiving and engaging at least a portion of the vial including the penetrable seal, the hollow piercing member having a first open end in fluid communication with the conduit and a second open end for piercing the penetrable seal, the vial socket assembly being moveable longitudinally relative to the housing in concert with the conduit;

d) in any order, connecting the first open end of the housing to the piston and fully inserting the vial into the vial socket so that the hollow piercing member pierces the penetrable seal and extends substantially the full length of the inner chamber and the second open end of the hollow piercing member is positioned adjacent the apex of the closed end of the inner chamber;

e) advancing the vial socket assembly towards the housing, causing the conduit to advance from the retracted position to the activated position to fluidly connect the chamber of the vessel and the inner chamber of the vial; and

f) transferring at least one fluid between the vessel and the maximum recovery vial through the conduit.

31. A method according to claim 30, wherein the vial is pre-filled with the at least one fluid and step (f) is performed by aspirating the at least one fluid from the vial into the vessel.

32. A method according to claim 30, wherein the vessel is pre-filled with the at least one fluid, the vial contains a pharmaceutical component, and step (f) is performed by injecting the at least one fluid from the vessel into the vial and aspirating the contents of the vial into the vessel.

33. A method according to claim 32, further comprising the step of mixing the contents of the vial after the step of injecting and before the step of aspirating.

34. A method according to claim 33, further comprising, subsequent to step (f), the step of detaching the vial socket assembly from the housing and using the housing as a plunger rod to dispense the contents of the vessel.

35. A vial socket assembly for use in a transfer assembly, the transfer assembly being adapted to transfer a fluid between a conduit and a vial, the vial having an inner chamber with an open end and a closed end and a penetrable seal covering the open end of the inner chamber, the closed end tapering inwardly toward an apex, the vial socket assembly comprising:

a vial socket for receiving and engaging at least a portion of the vial including the penetrable seal; and

a hollow piercing member having a first open end for fluid communication with the conduit and a second open end for piercing the penetrable seal of the vial when the vial is received in the vial socket, the hollow piercing member being sized to extend substantially the full length of the inner chamber of the vial so that the second open end is positioned adjacent the apex of the closed end of the inner chamber when the vial is fully engaged within the vial socket.

36. A vial, comprising:

an outer wall; and

an inner wall connected to and extending within the outer wall and defining an inner chamber, the inner chamber having an open end and an opposite closed end and tapering toward an apex at the closed end;

wherein the inner chamber has a first compartment of a first diameter and a second compartment of a second diameter smaller than the first diameter and wherein the first and second compartments are sized to contain together between about 0.5 mL and 1.0 mL of fluid and the second compartment is sized to contain between about 0.1 mL and 0.2 mL of fluid.