Device and method for pharmaceutical mixing and delivery

• US 20060178638A1
• Filed: 12/02/2005
• Published: 08/10/2006
• Est. Priority Date: 12/03/2004
• Status: Abandoned Application

• Current Assignee: Duoject Medical Systems, Inc
• Original Assignee: Duoject Medical Systems, Inc
• Inventors: Reynolds, David L.
• Application Number:
  US11/292,124
• Publication Number:
  US 20060178638A1
• Time in Patent Office: Days
• US Class Current: 604/191
• 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 device for delivery of a substance, comprising:

a socket member having a distal end and an open proximal end and a hollow body extending therebetween, the distal end being closed but for a fluid delivery passage therein;

a tubular container having a fluid communication end and an actuation end and being receivable in the socket member so that the fluid communication end is disposed toward the distal end of the socket member, the container having a first closure member disposed at the fluid communication end, a second closure member disposed at the actuation end, a piston within the container intermediate the first and second closure members and bypass means for enabling fluid to bypass the piston when the piston is in a bypass position;

an activation cap disposed around the actuation end of the container, the activation cap comprising a sleeve extending along a proximal portion of an outer surface of the container and being at least partly receivable within the proximal end of the socket member, the activation cap further comprising a base portion arranged to grip the actuation end of the container and to permit access to the second closure member through the actuation end; and

a plunger engageable with the second closure member for moving the second closure member within the container;

wherein, in a pre-activated state of the device, a first chamber is defined by the container, the second closure member and the piston, a second chamber is defined by the container, the piston and the first closure member and the first chamber is sealed from communication with the fluid delivery passage of the socket member and, in an activated state of the device, the fluid delivery passage is in fluid communication with the second chamber through the first closure member for delivery of the contents of the second chamber through the fluid delivery passage.

2. The device of claim 1, wherein the plunger is longitudinally extensible between a retracted position and an extended position.

3. The device of claim 2, wherein the plunger is adapted to be actuated in a first stroke in its retracted position and in a second stroke in its extended position.

4. The device of claim 3, wherein, in the pre-activated state of the device, the plunger is actuable in the first stroke and, in the activated state of the device, the plunger is actuable in the second stroke.

5. The device of claim 2, wherein the plunger comprises first and second coaxial members.

6. The device of claim 2, wherein the plunger is extensible between the retracted position and the extended position by movement of a shaft of the plunger relative to a sleeve of the plunger.

7. The device of claim 6, wherein the plunger has a screw-threaded distal portion for screw-threaded engagement with the second closure member.

8. The device of claim 6, wherein the shaft and sleeve have corresponding screw threads and extension of the plunger from the retracted position to the extended position is effected by a screw rotation of the shaft.

9. The device of claim 6, wherein the shaft is slidably received in the sleeve.

10. The device of claim 6, wherein the shaft and sleeve have cooperating portions tending to retain the plunger in the retracted position or the extended position.

11. The device of claim 6, wherein the shaft is substantially cylindrical and has a head portion having a larger diameter portion for cooperating with internal projections of the sleeve to prevent longitudinal detachment of the sleeve from the shaft.

12. The device of claim 1, wherein the plunger has a plurality of radial projections along a shaft thereof for interfering with the base portion of the activation cap during movement of the shaft and second closure member within the container to thereby retard such movement.

13. The device of claim 6, wherein the sleeve has a tapered outer surface.

14. The device of claim 13, wherein the taper angle of the tapered outer surface is between about 0.5 degrees and 2 degrees.

15. The device of claim 13, wherein in the first stroke of the plunger, the tapered outer surface of the sleeve progressively engages the base portion so as to provide progressively greater resistance to movement of the plunger in the first stroke.

16. The device of claim 1, wherein the second closure member has a distal projection and the piston has a proximal recess interlockingly engageable with the projection to enable the plunger to proximally withdraw the piston and the second closure member together in an aspiration action of the device.

17. The device of claim 1, wherein the device is movable from the pre-activated state to the activated state by moving the sleeve of the activation cap distally within the socket member so that the base portion of the activation cap is positioned adjacent the proximal end of the socket member.

18. The device of claim 1, wherein the socket member has penetration means disposed at the distal end thereof and directed generally proximally for penetrating the first closure member.

19. The device of claim 18, wherein the penetration means comprises a fluid passage for providing fluid communication of an external volume with an interior volume of the tubular container when the penetration means penetrates the first closure member.

20. The device of claim 18, wherein the penetration means comprises a spike integrally formed with the distal end of the socket member.

21. The device of claim 18, wherein the penetration means comprises a proximal end of a hollow needle received at least partly within the distal end of the socket member.

22. The device of claim 18, wherein the penetration means comprises a spike which, in a pre-activated state of the device, is slidably moveable in a distal direction.

23. The device of claim 1, wherein the distal end of the socket member comprises a cylindrical neck and lugs or threads disposed on an outer surface thereof for screw-threaded engagement with a female thread.

24. The device of claim 23, further comprising a connector sleeve having a female thread engageable with the lugs or threads and a fluid connection passage adapted to form a fluid connection between the fluid delivery passage and a vial received in a distal opening of the connector sleeve.

25. The device of claim 24, wherein, in the activated state of the device, a fluid connection is established between the vial via the fluid connection passage and the fluid delivery passage, whereby fluid is communicable between the second chamber and an interior volume of the vial.

26. The device of claim 24, wherein the vial defines a third chamber and the device is operable to mix the contents of the first, second and third chambers.

27. The device of claim 26, wherein the device is operable to mix the contents of the first and second chambers together and then mix the mixed contents with the contents of the third chamber.

28. The device of claim 1, wherein the tubular container has a neck portion disposed toward said fluid communication end and wherein the first closure member is disposed at least partly within the neck portion.

29. The device of claim 28, wherein the neck portion is substantially straight.

30. The device of claim 28, wherein the first closure member is a stopper received within the neck portion and having a recess therein extending distally from a proximal face of the stopper so as to define a thin central portion for penetration thereof by the penetration means.

31. The device of claim 26, wherein the first closure member is a piston received within the neck portion and having a recess therein extending distally from a proximal face of the piston so as to define a thin central portion for penetration thereof by the penetration means.

32. The device of claim 29, wherein the first closure member is engaged with a proximal protrusion of the distal end of the socket member.

33. The device of claim 32, wherein the first closure member is engaged in screw threaded connection with the proximal protrusion.

34. The device of claim 1, wherein the bypass means comprises at least one longitudinally extending recess formed in a wall of the tubular container.

35. The device of claim 1, wherein the bypass means comprises an interiorly directed deformation of a longitudinal portion of a wall of the tubular container.

36. The device of claim 35, wherein the deformation is created by forming an inwardly directed recess in an outer surface of the wall.

37. The device of claim 35, wherein in the bypass position, the piston is deformed by the interior deformation of the wall so as to partially separate the piston from the wall of the tubular container.

38. The device of claim 34, wherein the bypass means comprises a plurality of recesses formed in the wall of the tubular container.

39. The device of claim 38, wherein the recesses are evenly spaced around a circumference of the wall.

40. The device of claim 38, wherein the bypass means comprises two to six recesses.

41. The device of claim 34, wherein the wall extends outwardly from a nominal exterior surface of the wall at the position of each recess by about 0.3 mm or less.

42. The device of claim 34, wherein each recess has a curved cross-sectional profile.

43. A method of delivery of a substance, comprising the steps of:

providing a delivery device comprising a syringe socket, a cartridge containing separate first and second constituents and at least partly received in the syringe socket, an axially extensible plunger extensible between a retracted position and an extended position and fluid connection means for providing fluid communication between a volume internal of the syringe socket and an external volume thereof;

activating the delivery device by inserting a part of the fluid connection means into the cartridge and thereby establishing fluid communication between an internal volume of the cartridge and the external volume;

actuating the plunger in its retracted position, in a first stroke of the plunger, to cause the first constituent to mix with the second constituent and form the substance;

extending the plunger to the extended position; and

actuating the plunger in its extended position in a second stroke of the plunger to deliver the substance to the external volume via the fluid connection means.

44. The method of claim 43, wherein the delivery device further comprises an activation cap engaging a proximal end of the cartridge and at least partly received in the syringe socket and the step of activating includes moving the activation cap axially within the syringe socket to force insertion of the part of the fluid connection means into the cartridge.

45. The method of claim 44, further comprising retarding the plunger in its first stroke by interference of an outer surface of the plunger with a base portion of the activation cap.

46. The method of claim 43, wherein the step of extending comprises screw rotation of a first member of the plunger relative to a second member of the plunger.

47. The method of claim 43, wherein the step of extending comprises slidably moving a first member of the plunger relative to a second member of the plunger.

48. The method of claim 43, wherein the external volume is defined by a vial containing a third constituent and delivering the substance to the external volume mixes the substance with the third constituent, the method further comprising the step of aspirating the mixed substance and third constituent via the fluid connection means into the cartridge by activating the plunger in its extended position in a third stroke of opposite direction to the first and second strokes;

selecting another external volume; and

activating the plunger in its extended position in a fourth stroke of the same direction of the first and second strokes to deliver the mixed substance and third constituent to the other volume via the fluid connection means.

49. A device for delivery of a pharmaceutical substance, comprising:

a syringe socket having a fluid connection end;

a cartridge at least partly received in the syringe socket, the cartridge defining a first chamber containing a first constituent, a second chamber containing a second constituent and bypass means for fluidly connecting the first and second chambers to allow mixing of the first and second constituents;

a connection part comprising fluid communication means and first and second engaging portions, the first engaging portion being adapted to engage the syringe socket at the fluid connection end and the second engaging portion being adapted to engage a head portion of a container having a third chamber containing a third constituent, wherein, in an activated position of the device, the second chamber is in fluid communication with the fluid communication means via the fluid connection end, whereby, when the head portion of the container is engaged with the second engaging portion and the fluid communication means is in fluid communication with the third chamber, mixed first and second constituent is fluidly mixable with the third constituent to form the pharmaceutical substance; and

means for aspirating the third constituent into the cartridge for mixing and subsequent delivery of the pharmaceutical substance via the fluid connection end of the syringe socket.

50. A device for mixing constituents of a pharmaceutical substance, comprising:

first, second and third chambers defined by the device, the first, second and third chambers containing respective first, second and third constituents and being oriented in sequence along a longitudinal axis of the device;

wherein the device is arranged such that, in an activated position, the first, second and third constituents may be mixed by actuation of a plunger upon a piston associated with the first chamber.

51. The device of claim 50, wherein in the activated position, initial actuation of the plunger causes the first constituent to flow into the second chamber, thereby mixing the first and second constituents, and further actuation of the plunger causes mixed first and second constituent to flow into the third chamber and thereby mix the first and second constituent with the third constituent.

52. The device of claim 51, wherein still further actuation of the plunger causes mixed first, second and third constituent to flow into the second chamber.

53. The device of claim 50, wherein the first, second and third chambers are at least partly received within an elongate tubular housing.

54. The device of claim 53, wherein the housing comprises first and second detachable parts, the first detachable part at least partly receiving the first and second chambers and the second detachable part at least partly receiving the third chamber.

55. A method of mixing first and second constituents of a substance, comprising the steps of:

providing a delivery device comprising a socket assembly, a cartridge separately containing the first and second constituents and at least partly received in the socket assembly, a plunger engageable with a closure member of the cartridge and fluid connection means for providing fluid communication between a volume internal of the socket assembly and an external volume thereof the socket assembly having a base portion engaging a proximal end of the cartridge and defining a base opening;

activating the delivery device by inserting a part of the fluid connection means into the cartridge and thereby establishing fluid communication between an internal volume of the cartridge and the external volume;

actuating the plunger to move the closure member within the cartridge and to thereby cause the first constituent to mix with the second constituent and form the substance, such mixing being performed in a first stroke of the plunger; and

interfering the base portion of the socket assembly with an outer surface of the plunger during actuation of the plunger to retard movement of the plunger and the closure member during the first stroke.

56. The method of claim 55, further comprising the step of:

actuating the plunger in a second stroke to deliver the substance to the external volume.

57. The method of claim 56, further comprising the step of:

allowing uninterfered movement of the plunger relative to the base portion of the socket assembly in the second stroke.

58. The method of claim 55, wherein the external volume is a vial.

59. The method of claim 55, wherein the external volume is a patient body.

60. The method of claim 55, wherein the plunger is extensible and the method further comprises extending the plunger from a retracted position to an extended position and actuating the plunger in a second stroke to deliver the substance to the external volume.

61. The method of claim 60, further comprising the step of:

allowing uninterfered movement of the plunger relative to the base portion of the socket assembly in the second stroke.

62. The method of claim 55, wherein the socket assembly comprises a syringe socket and an activation cap at least partly received in the syringe socket, the activation cap having the base portion.