Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same

• US 6,719,719 B2
• Filed: 05/23/2001
• Issued: 04/13/2004
• Est. Priority Date: 11/13/1998
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Carmel, Ehoud, Lavi, Gilad, Tsals, Izrail, Yigal, Gil
• Primary Examiner(s): Casler, Biran L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/863,539
• Publication Number:
  US 20020004643A1
• Time in Patent Office: 1,056 Days
• Field of Search: 604/82, 604/83, 604/84, 604/85, 604/86, 604/87, 604/88, 604/91, 604/92, 604/183, 604/191, 604/200-201, 604/244, 604/411, 604/412, 604/413, 604/414, 604/416, 128/912
• US Class Current: 604/82
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2082 for gas 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: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3223 Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2205/215 Tilt detection, e.g. for warning or shut-off
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/38 : using hydrophilic or hydrophobic filters

Abstract

A spike for facilitating the introduction of liquid under pressure into a container containing a substance is provided which includes an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, where the distal end has a sharp, pointed tip. An introduction channel is located within the spike shaft for receiving liquid into the container where a portion of the introduction channel is angled to cause liquid to travel out of the introduction channel in a direction non-parallel to the longitudinal axis of the spike shaft. An extraction channel may be included within the spike shaft for removing liquid from the container, where the extraction channel extends through the elongate spike shaft towards the proximally located end portion.

Claims

1. A spike for facilitating the introduction of liquid under pressure into a container containing a substance, said spike comprising:

(a) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;

(b) an introduction channel within said spike shaft for receiving liquid into the container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; and

(c) an extraction channel within said spike shaft for removing liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion, said extraction channel not coaxial with said introduction channel said extraction channel having an inlet opening in said spike shaft for receiving liquid from said container and said introduction channel having a diluent outlet opening in said spike shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

2. The spike of claim 1, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

3. The spike of claim 1, wherein said introduction channel has a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

4. The spike of claim 3, wherein said exit leg extends from said main leg perpendicular to said longitudinal axis.

5. A device for reconstituting a substance in a first liquid to provide a resulting liquid comprising the first liquid and the substance subsequent to being reconstituted, the device, comprising:

(a) a chamber containing the first liquid under pressure;

(b) a container containing the substance, said container having at least one container side wall and a capped end, said capped end having a cap having a pierceable portion;

(c) a spike extending through said pierceable portion into said container, said spike comprising;

(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip; and

(ii) an introduction channel within said spike shaft for receiving the first liquid into said container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; and

(d) an extraction channel within said spike shaft for removing the resulting liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion, said extraction channel not coaxial with said introduction channel, said extraction channel having an inlet opening in said shaft and said introduction channel having a diluent outlet opening in said shaft and wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

6. The device of claim 5, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

7. The device of claim 5, wherein said introduction channel has a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

8. The device of claim 7, wherein said exit leg is perpendicular to said longitudinal axis.

9. The device of claim 5, wherein said pierceable portion is a rubber membrane.

10. A hand-held drug reconstitution and injection device, comprising:

(a) a diluent vial containing a diluent and having an elongate diluent vial spike extending through a diluent vial cap on said diluent vial, said diluent vial spike comprising;

(i) a distal end located inside said diluent vial, a diluent vial spike side wall, and a proximally located lower portion located outside said diluent vial;

(ii) a diluent vial spike air inlet conduit extending between an air inlet conduit opening in said proximally located lower portion and a diluent vial spike side wall opening adjacent said distal end; and

(iii) a diluent exit conduit extending between an entrance opening on said diluent vial spike side wall adjacent said distal end and an exit opening on said proximally located lower portion of said diluent vial spike;

(b) a drug vial containing a substance to be reconstituted, said drug vial having at least one drug vial side wall and a capped end, said capped end having a cap having a pierceable membrane, said drug vial having a drug vial spike extending through said drug vial cap on said drug vial, said drug vial spike comprising;

(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end located inside said drug vial, and a proximally located end portion located outside said drug vial, said distal end having a sharp, pointed tip;

(ii) an introduction channel within said spike shaft for receiving the diluent into said drug vial, a portion of said introduction channel angled to cause the diluent to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;

said introduction channel having a diluent inlet opening on said proximally located end portion and a diluent outlet opening in said spike side wall adjacent said distal end; and

(iii) an extraction channel within said spike shaft for removing a reconstituted drug from said drug vial, said extraction channel extending from an extraction channel inlet opening in said spike side wall adjacent said distal end to an extraction channel outlet opening in the proximally located end portion;

(c) an air conduit extending between an air pressurizer and said air inlet conduit opening;

(d) a diluent conduit extending between said exit opening and said diluent inlet opening, for transfer of said diluent through said diluent conduit from said diluent vial to said drug vial; and

(e) a reconstituted drug conduit extending between said extraction channel outlet opening and a needle having an orifice therein for injection into a patient.

11. The spike of claim 10, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

12. The spike of claim 10, wherein said introduction channel has a main leg extending from said diluent inlet opening towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to said diluent outlet opening in said spike side wall.

13. The device of claim 10, wherein said exit leg is perpendicular to said longitudinal axis.

14. The device of claim 10, wherein said extraction channel inlet opening is closer to said proximally located end portion than said diluent outlet opening.

15. The device of claim 10, wherein said reconstituted drug conduit includes an air separator to separate air from the reconstituted drug prior to injection.

16. The device of claim 15, wherein the air separator is a hydrophilic membrane.

17. The device of claim 10, wherein the air pressurizer is a cylinder and plunger.

18. A spike for the introduction of liquid under pressure into a container and for the withdrawing of liquid from the container, said spike comprising:

(a) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;

(b) an introduction channel within said spike shaft for receiving liquid into said container, said introduction channel including a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall;

(c) an extraction channel within said spike shaft for removing liquid from said container, and

(d) said extraction channel having an inlet opening on said spike shaft inside the container for receiving liquid from the container and said introduction channel having a diluent outlet opening on said spike shaft for delivering liquid into said container, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

19. A method for introducing liquid under pressure into a container containing a substance, comprising the steps of:

(a) providing an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;

(b) providing an introduction channel within said spike shaft, a portion of said introduction channel angled to cause the liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;

(c) providing the liquid under pressure into said container through said introduction channel such that the liquid travels out of said spike shaft in a direction non-parallel to said longitudinal axis of said spike shaft; and

(d) providing an extraction channel within said spike shaft, said extraction channel extending through said elongate spike shaft towards said proximally located end portion and including the step of removing liquid from said container through said extraction channel.

20. The method of claim 19, wherein the step of providing said introduction channel includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

21. The method of claim 19, wherein said step of providing said introduction channel includes providing a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

22. The method of claim 21, wherein said step including providing said exit leg includes providing said exit leg extending from said main leg perpendicular to said longitudinal axis.

23. The method of claim 19, wherein said step of providing said extraction channel includes providing an inlet opening in said spike shaft for receiving liquid from said container and wherein said step of providing said introduction channel includes providing a diluent outlet opening in said spike shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

24. A method for reconstituting a substance in a first liquid to provide a resulting liquid comprising the first liquid and the substance subsequent to being reconstituted, said method comprising:

(a) providing a chamber containing the first liquid;

(b) providing a container containing the substance, said container having at least one container side wall and a capped end, said capped end having a cap having a pierceable portion; and

(c) providing a spike comprising;

(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip; and

(ii) an introduction channel within said spike shaft for receiving the first liquid into said container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;

(d) providing a diluent conduit extending between chamber and said introduction channel of said spike, for transfer of said diluent through said diluent conduit from said chamber to said container;

(e) piercing said spike through said pierceable portion into said container; and

(f) pressurizing said first liquid in said chamber to cause said first liquid to flow from said chamber, through said diluent conduit and into said container through said introduction channel.

25. The method of claim 24, the step of providing an extraction channel within said spike shaft for removing the resulting liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion.

26. The method of claim 24, wherein the step of providing the introduction channel includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

27. The method of claim 24, wherein the step of providing said introduction channel includes providing a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

28. The method of claim 27, wherein said step including providing said exit leg includes providing said exit leg perpendicular to said longitudinal axis.

29. The method of claim 25, wherein said step of providing said extraction channel includes providing an inlet opening in said shaft and said step of providing said introduction channel includes providing a diluent outlet opening in said shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

30. The method of claim 24, wherein said step including providing said pierceable portion includes providing a rubber membrane.

31. A method for reconstituting a drug, comprising:

(a) providing a diluent vial spike comprising;

(i) a distal end, a diluent vial spike side wall, and a proximally located lower portion;

(ii) a diluent vial spike air inlet conduit extending between an air inlet conduit opening in said proximally located lower portion and a diluent vial spike side wall opening adjacent said distal end; and

(iii) a diluent exit conduit extending between an entrance opening on said diluent vial spike side wall adjacent said distal end and an exit opening on said proximally located lower portion of said diluent vial spike;

(b) providing a diluent vial having a diluent vial cap and containing a diluent;

(c) extending said distal end of said elongate diluent vial spike through said diluent vial cap;

(d) providing a drug vial containing a substance to be reconstituted, said drug vial having at least one drug vial side wall and a capped end, said capped end having a cap having a pierceable membrane;

(e) providing a drug vial spike comprising;

(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end, and a proximally located end portion, said distal end having a sharp, pointed tip;

(ii) an introduction channel within said spike shaft for receiving the diluent into said drug vial, a portion of said introduction channel angled to cause the diluent to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;

said introduction channel having a diluent inlet opening on said proximally located end portion and a diluent outlet opening in said spike side wall adjacent said distal end; and

(iii) an extraction channel within said spike shaft for removing a reconstituted drug from said drug vial, said extraction channel extending from an extraction channel inlet opening in said spike side wall adjacent said distal end to an extraction channel outlet opening in the proximally located end portion;

(f) piercing said drug vial spike through said drug vial cap such that said distal end of said drug vial spike is located inside said drug vial and said proximally located end portion is located outside said drug vial;

(g) providing an air conduit extending between an air pressurizer and said air inlet conduit opening;

(h) providing a diluent conduit extending between said exit opening and said diluent inlet opening, for transfer of said diluent through said diluent conduit from said diluent vial to said drug vial;

(i) providing a reconstituted drug conduit extending between said extraction channel outlet opening and a needle having an orifice therein for injection into a patient; and

(j) pressurizing said diluent vial using said air pressurizer to cause air to flow through said air conduit to said air inlet conduit opening, to cause diluent to flow out of said diluent exit conduit, through said diluent conduit, and through said introduction channel to mix with said substance and to cause said reconstituted drug to flow through said extraction channel and through said orifice in said needle.

32. The method of claim 31, wherein said step including providing said introduction channel is includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

33. The method of claim 31, wherein said step of providing said introduction channel includes providing a main leg extending from said diluent inlet opening towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to said diluent outlet opening in said spike side wall.

34. The method of claim 31, wherein said step including providing said introduction channel includes providing said exit leg perpendicular to said longitudinal axis.

35. The method of claim 31, wherein the step of providing said extraction channel includes providing said extraction channel inlet opening closer to said proximally located end portion than said diluent outlet opening.

36. The method of claim 31, wherein said step including providing said reconstituted drug conduit includes providing an air separator to separate air from the reconstituted drug prior to injection.

37. The method claim 36, wherein step of providing the air separator includes providing a hydrophilic membrane.

38. The method of claim 31, wherein the step including providing an air pressurizer includes providing a cylinder and plunger.

39. A method for introducing liquid under pressure into a container and for withdrawing liquid from the container, said method comprising:

(a) providing an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;

(b) providing an introduction channel within said spike shaft for receiving liquid into said container, said introduction channel having a diluent outlet opening on said spike shaft for delivering liquid into said container, a portion of said introduction channel being non-parallel to said longitudinal axis of said spike shaft;

(c) providing an extraction channel within said spike shaft for removing liquid from said container, said extraction channel having an inlet opening on said spike shaft inside the container for receiving liquid from the container, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening;

(d) receiving liquid into said container through said introduction channel; and

(e) withdrawing liquid from said container through said extraction channel.