Pharmaceutical cartridge assembly and method of filling same

• US 20060178644A1
• Filed: 12/02/2005
• Published: 08/10/2006
• Est. Priority Date: 12/03/2004
• Status: Abandoned Application

• Current Assignee: Douject Medical Systems, Inc.
• Original Assignee: Douject Medical Systems, Inc.
• Inventors: Reynolds, David L.
• Application Number:
  US11/292,092
• Publication Number:
  US 20060178644A1
• Time in Patent Office: Days
• US Class Current: 604/232
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2455 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/502 for blocking the piston
• CPC Class Codes: A61M 5/5066 Means for preventing re-use by disconnection of piston and piston-rod
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B65B 3/003 : Filling medical containers such as ampoules, vials, syringes or the like

Abstract

Embodiments of the invention relate generally to cartridges, devices and methods for pharmaceutical constituents for storage, mixing and delivery. Particular embodiments relate to a device and method for pharmaceutical constituent mixing and delivery using a double-chambered cartridge within a socket member, for use as part of a syringe device. Other embodiments relate to a cartridge assembly for storing the pharmaceutical constituents prior to mixing and a method of forming the cartridge assembly. Still further embodiments relate to an extensible plunger for actuation of the delivery device. The extensible plunger is actuated in a first stroke while in its retracted state to mix the constituents and is actuated in a second stroke in its extended state to deliver the mixed constituents to an external volume.

Claims

1. A filled cartridge for mixing pharmaceutical constituents therewithin, the cartridge comprising:

a hollow tube, the hollow tube having a wall and opposed first and second ends;

a bypass portion formed in the wall intermediate the first and second ends, the bypass portion comprising at least one inward deformation of the wall;

a first piston disposed within the hollow tube between the bypass portion and the first end;

a second piston disposed within the hollow tube away from the bypass portion and toward the first end so that the first and second pistons define a first chamber therebetween;

a first constituent disposed in the first chamber;

a closure disposed at least partially within the second end so that the first piston and the closure define a second chamber therebetween; and

a second constituent disposed in the second chamber;

wherein the first and second pistons are movable within the hollow tube and wherein, when the first piston is received within the bypass portion, at least one bypass channel is formed between the first piston and the wall, thereby allowing fluid communication between the first and second chambers for mixing the first and second constituents.

2. A cartridge assembly, comprising:

the filled cartridge of claim 1;

and

a support cap disposed around and engaging the first end of the hollow tube, the support cap having a base portion, the base portion having an apron of greater diameter than an outside diameter of the hollow tube and having a footprint of a circular shape when the cartridge assembly is positioned upright so that the filled cartridge is disposed vertically.

3. A partially filled cartridge, the cartridge comprising:

a hollow tube, the hollow tube having a wall and opposed first and second ends;

a bypass portion formed in the wall intermediate the first and second ends, the bypass portion comprising at least one inward deformation of the wall;

a first piston disposed within the hollow tube between the bypass portion and the first end;

a second piston disposed within the hollow tube away from the bypass portion and toward the first end so that the first and second pistons define a first chamber therebetween; and

a first constituent disposed in the first chamber;

wherein the first and second pistons are movable within the hollow tube and wherein, when the first piston is received within the bypass portion, at least one bypass channel is formed between the first piston and the wall, thereby allowing fluid communication between the first chamber and a second chamber, the second chamber being defined by the first piston, the wall and the second end.

4. A cartridge assembly, comprising:

the partially filled cartridge of claim 3;

and

a support cap disposed around and engaging the first end of the hollow tube, the support cap having a base portion, the base portion having an apron of greater diameter than an outside diameter of the hollow tube and having a footprint of a circular shape when the cartridge assembly is positioned upright so that the filled cartridge is disposed vertically.

5. A method of forming a cartridge assembly, comprising the steps of:

providing a cartridge tube, the cartridge tube being hollow and having a wall, first and second ends and a bypass portion, the bypass portion being formed intermediate the first and second ends;

inserting a first piston in the cartridge tube intermediate the first end and the bypass portion;

orienting the cartridge tube so that the first end is upward of the second end;

filling a first constituent into the cartridge tube between the first piston and the first end;

inserting a second piston into the cartridge tube between the first constituent and the first end so that the first constituent is fluidly sealed between the first and second pistons; and

fitting the first end of the cartridge tube into a support cap to form a partially filled cartridge assembly, the support cap having a support footprint substantially larger than a tube footprint of the cartridge tube, whereby the cartridge tube can be transported in an upright manner while supported by the support cap.

6. The method of claim 5, wherein the first constituent is a fluid and further comprising the steps of:

transporting the partially filled cartridge assembly to a powder filling facility;

sterilizing the partially filled cartridge assembly; and

filling a second constituent into the cartridge tube between the first piston and the second end, the second constituent being in powder form.

7. The method of claim 6, further comprising the step of sealing the second end to form a filled cartridge assembly.

8. The method of claim 5, further comprising the step of inserting the second end into a hollow syringe socket so that the second end is received within a distal end of the syringe socket and the support cap is partially received within a proximal end of the syringe socket.

9. The method of claim 7, wherein the step of sealing comprises inserting a closure member at least partially into the second end.

10. The method of claim 9, wherein the closure member is a third piston.

11. The method of claim 5, wherein the bypass portion comprises at least one inward deformation of the wall.

12. The methods of claim 5, wherein the bypass portion comprises at least one longitudinally extending recess formed in the wall.

13. The method of claim 12, wherein the bypass portion comprises a plurality of recesses formed in the wall.

14. The method of claim 13, wherein the recesses are evenly spaced around a circumference of the wall.

15. The method of claim 13, wherein the bypass portion comprises two to six recesses.

16. The method of claim 12, wherein the wall extends outwardly from a nominal exterior surface of the wall at the portion of each recess by about 0.3 mm or less.

17. The method of claim 12, wherein each recess has a curved cross-sectional profile.

18. A method of assembling a filled cartridge, the method comprising:

forming at a first filling facility a partially filled cartridge, the partially filled cartridge defining a sealed first chamber containing a first constituent and an open second chamber;

transporting the partially filled cartridge to a second filling facility;

sterilizing the partially filled cartridge;

filling a second constituent into the second chamber; and

sealing the second chamber.

19. The method of claim 18, wherein the first constituent comprises a fluid and the second constituent comprises a powder.

20. A method of forming a cartridge tube, comprising the steps of:

providing a hollow tube having a wall and first and second ends; and

deforming the wall inwardly from the outside of the hollow tube so as to form an inward deformation of an internal surface of the wall.

21. The method of claim 20, further comprising, prior to the step of deforming, the step of thermally softening the hollow tube and, after the step of deforming, the step of thermally setting the inward deformation.

22. The method of claim 20, wherein the inward deformation is formed longitudinally, intermediate the first and second ends, using a pressing tool.

23. The method of claim 20, wherein the inward deformation extends inwardly of the internal surface by between 0.7 mm and 1.2 mm.

24. The method of claim 23, wherein the inward deformation extends inwardly of the internal surface by between 0.8 mm and 1.0 mm.

25. The method of claim 24, wherein the inward deformation extends inwardly of the internal surface by about 0.9 mm.

26. The method of claim 20, wherein the inward deformation is formed to have a longitudinal length of about 13.3 mm.

27. The method of claim 20, wherein the step of deforming further comprises supporting the internal surface of the wall adjacent the inward deformation.

28. A cartridge tube for a pharmaceutical cartridge, the cartridge tube comprising:

a hollow tube, the hollow tube having a wall and opposed first and second ends; and

a bypass portion formed in the wall intermediate the first and second ends, the bypass portion comprising at least one inward deformation of the wall.

29. The cartridge tube of claim 28, wherein the at least one inward deformation is rounded.

30. The cartridge tube of claim 28, wherein the at least one inward deformation extends substantially radially inwardly relative to a nominal internal surface of the wall.

31. The cartridge tube of claim 28, wherein a contour of the wall is at least partially inwardly deformed at the bypass portion.

32. The cartridge tube of claim 28, wherein the at least one inward deformation extends inwardly of the nominal internal surface of the wall by between 0.7 mm and 1.2 mm.

33. The cartridge tube of claim 32, wherein the at least one inward deformation extends inwardly of the nominal internal surface of the wall by between 0.8 mm and 1.0 mm.

34. The cartridge tube of claim 33, wherein the at least one inward deformation extends inwardly of the nominal internal surface of the wall by about 0.9 mm.

35. The cartridge tube of claim 28, wherein a width of the at least one inward deformation is about 2.0 mm to 2.5 mm.

36. The cartridge tube of claim 28, wherein a length of the at least one inward deformation is about 12.5 mm to 14.0 mm.

37. The cartridge tube of claim 35, wherein the width is about 2.25 mm.

38. The cartridge tube of claim 36, wherein the length is about 13.3 mm.

39. The cartridge tube of claim 28, wherein the hollow tube is formed of glass.

40. The cartridge tube of claim 39, wherein the hollow tube is formed of borosilicate glass.

41. The cartridge tube of claim 39, wherein the glass contains cerium oxide.

42. The cartridge tube of claim 28, wherein the bypass portion is located closer to the second end than to the first end.

43. The cartridge tube of claim 28, wherein the bypass portion comprises two inward deformations of the wall.

44. The cartridge tube of claim 43, wherein the two inward deformations are adjacent each other.

45. The cartridge tube of claim 43, wherein the two inward deformations are spaced from each other.

46. The cartridge tube of claim 43, wherein the two inward deformations are substantially parallel and longitudinally oriented.

47. The cartridge tube of claim 44, wherein the two inward deformations define at least one bypass channel so that, when a deformable piston is received within the bypass portion, the two inward deformations cause the piston to inwardly deform and partially separate from the wall, thereby allowing fluid flow along the at least one bypass channel.

48. The cartridge tube of claim 47, wherein one bypass channel is defined intermediate the two inward deformations.

49. The cartridge tube of claim 47, wherein first, second and third bypass channels are defined by the two inward deformations, the first bypass channel being defined intermediate the two inward deformations and the second and third bypass channels being defined on respective opposite outside sides of the two inward deformations.

50. The cartridge tube of claim 28, wherein the hollow tube is adapted to receive a closure member at least partially within a neck portion of the second end.

51. The cartridge tube of claim 50, wherein the neck portion is straight.

52. The cartridge tube of claim 50, wherein the neck portion is circumferentially detented and circumferentially flanged.

53. A method of forming a cartridge tube, comprising the steps of:

providing a hollow tube having a wall and first and second ends; and

deforming the wall inwardly from the outside of the hollow tube so as to form first and second inward deformations of an internal surface of the wall.

54. The method of claim 53, wherein the first and second inward deformations are formed longitudinally, intermediate the first and second ends, using a pressing tool.

55. The method of claim 53, wherein the first and second inward deformations are formed simultaneously.

56. The method of claim 53, wherein the first and second inward deformations are formed in sequence.

57. The method of claim 53, wherein the first and second inward deformations are formed adjacently.

58. The method of claim 57, wherein the first and second inward deformations have an angular separation, relative to a center of the hollow tube, of between about 30 to 40 degrees.

59. The method of claim 58, wherein the angular separation is about 35 degrees.

60. The method of claim 53, wherein the step of deforming further comprises supporting the internal surface of the wall adjacent the first and second inward deformations.

61. The method of claim 53, wherein the first and second inward deformations define a channel therebetween.

62. The method of claim 53, further comprising, prior to the step of deforming, the step of thermally softening the hollow tube and, after the step of deforming, the step of thermally setting the first and second inward deformations.