MULTI-RESERVOIR INFUSION PUMP SYSTEMS AND METHODS

• US 20130053816A1
• Filed: 07/24/2012
• Published: 02/28/2013
• Est. Priority Date: 07/25/2011
• Status: Abandoned Application

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: DiPERNA, Paul M., GRIFFIE, Steve
• Application Number:
  US13/557,163
• Publication Number:
  US 20130053816A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body

Abstract

Embodiments are directed to multi-reservoir infusion devices, systems, and methods of using the same for dispensing materials. In some cases, the devices, systems and methods may be used for infusing a material such as medicament, e.g., insulin, into a body in need thereof.

Claims

1. An infusion pump cartridge for delivering fluid to a patient, comprising:

a delivery mechanism including;

a first inlet port,

a second inlet port spaced from the first inlet port,

at least one outlet port which is spaced from the first inlet port and second inlet port, and

a constrained variable volume which is translatable between a position in fluid communication with the first inlet port, a position in fluid communication with the second inlet port and a position in fluid communication with an outlet port and which is configured to expand while in fluid communication with an inlet port and contract while in fluid communication with an outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port; and

a second fluid reservoir including an interior volume in fluid communication with the second inlet port.

2. The cartridge of claim 1 wherein the constrained variable volume is configured to expand and contract due to exertion of a translational force on a boundary section of the constrained variable volume.

4. The infusion pump of claim 1 wherein the drive mechanism is configured to expand or contract the constrained variable volume by exerting translational force through a boundary section of the constrained variable volume.

3. An infusion pump for delivering fluids to a patient, comprising:

a delivery mechanism including;

a first inlet port,

a second inlet port spaced from the first inlet port,

at least one outlet port which is spaced from the first inlet port and second inlet port, and

a constrained variable volume translatable between a position in fluid communication with the first inlet port, a position in fluid communication with the second inlet port and a position in fluid communication with an outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the constrained variable volume, which is configured to translate the constrained variable volume from each of the inlet ports to an outlet port and which is configured to expand and contract the constrained variable volume of the spool.

5. An infusion pump for delivering fluids to a patient, comprising:

a delivery mechanism including;

an axial bore including a longitudinal axis and an interior volume,

a first inlet port in fluid communication with the interior volume of the axial bore,

a second inlet port axially spaced from the first inlet port and in fluid communication with the interior volume of the axial bore,

at least one outlet port which is axially spaced from the first inlet port and second inlet port and which is in fluid communication with the interior volume of the axial bore, and

a spool which is disposed within the axial bore, which is axially translatable within the axial bore and which forms a constrained variable volume in conjunction with an interior surface of the axial bore;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the spool, which is configured to axially translate the constrained variable volume from each of the inlet ports to an outlet port and which is configured to expand or contract the constrained variable volume of the spool by exerting translational axial force through a boundary section of the constrained variable volume.

6. The infusion pump of claim 5 wherein the drive mechanism is configured to expand or contract the constrained variable volume by exerting translational axial force through a boundary section of the constrained variable volume.

7. The infusion pump of claim 5 wherein the axial bore, first inlet port, second inlet port and at least one outlet port are disposed within a housing of the delivery mechanism.

8. The infusion pump of claim 5 wherein the bore comprises a plurality of inlet ports in fluid communication with a single fluid reservoir and the delivery mechanism is configured such that the constrained variable volume is positionable to overlap all of the plurality of inlet ports of this single fluid reservoir independent of an overlap with an inlet port in fluid communication with another fluid reservoir.

9. The infusion pump of claim 5 wherein the constrained variable volume is formed between a first seal disposed around the spool, a second seal disposed around the spool, an outer surface of the spool body at least between the first and second seal and an interior surface of the bore between the first and second seal, the first and second seals being axially translatable relative to each other but mechanically constrained to a maximum and minimum axial separation.

10. The infusion pump of claim 9 wherein the first seal is disposed around a first section of the spool and the second seal is disposed around a second section of the spool and wherein the first section of the spool and second section of the spool are coupled together by a limited displacement coupling which is configured to allow axial movement of the first and second spool sections relative to each other for a limited axial distance.

11. The infusion pump of claim 10 wherein the drive mechanism is coupled to the first spool section and coupled to the second spool section through the limited displacement coupling.

12. The infusion pump of claim 9 wherein the variable volume of the spool is bounded by an outside surface of the spool, an inside surface of the bore, a first seal disposed between the spool and the bore, the first seal being substantially axially fixed relative to the spool but displaceable relative to an inside surface of the bore and a second seal which is disposed between an outside surface of a slide portion of the spool and inside surface of the bore, which is configured to slide over the slide portion of the spool, which forms a substantially fluid tight but displaceable seal between an outside surface of the slide portion and the inside surface of the bore and which has a greater frictional resistance to sliding against the inside surface of the bore relative to the frictional resistance to sliding against the slide portion of the spool.

13. The infusion pump of claim 12 wherein a shaft of the spool is axially continuous and rigid along an axial direction and the drive mechanism is directly coupled to the rigid shaft.

14. The infusion pump of claim 12 wherein the slide portion of the spool comprises a smooth reduced diameter axial section of a shaft of the spool having a substantially continuous transverse cross section, a first stop at an end of the slide portion which is configured to limit axial movement of the second seal over the slide portion and a second stop opposite the slide portion of the first stop that is also configured to limit axial movement of the second seal over the slide portion.

15. The infusion pump of claim 5 wherein an axial separation of the first inlet port from the second inlet port is greater than a maximum axial length of the constrained variable volume.

16. The infusion pump of claim 5 wherein an axial separation of the inlet ports from the outlet port is greater than a maximum axial length of the constrained variable volume.

17. The infusion pump of claim 5 wherein an axial separation of the first inlet port from the second inlet port is greater than a maximum displacement between the first seal and the second seal.

18. The infusion pump of claim 5 wherein a minimum axial separation of the inlet ports from the outlet port is greater than a maximum displacement between the first seal and the second seal.

19. The infusion pump of claim 5 further comprising a proximal bore seal and a distal bore seal disposed between an outside surface of the spool and the inside surface of the bore at respective proximal and distal ends of the spool, the bore seals being configured to isolate the inlet and outlet ports of the bore from the surrounding environment.

20. The infusion pump of claim 5 wherein the first and second fluid reservoirs comprise collapsible reservoirs bounded by a thin flexible fluid tight material.

21. The infusion pump of claim 20 further comprising a substantially rigid fluid tight shell disposed about the first and second fluid reservoirs with a fluid tight interior volume being formed between an inside surface of the rigid shell and respective outside surfaces of the first and second fluid reservoirs.

22. The infusion pump of claim 21 wherein the interior volume of the rigid shell comprises a vented volume and further comprising a vent port in fluid communication between the interior volume of the bore and an interior volume of the vented volume and a vent outlet port in fluid communication between an interior volume of the bore and the ambient atmosphere.

23. The infusion pump of claim 22 further comprising a pressure sensor disposed in operative fluid communication with the vented volume.

24. The infusion pump of claim 5 further comprising a controller operatively coupled to the drive mechanism.

25. The infusion pump of claim 24 wherein the controller comprises at least one processor and a memory device operatively coupled to the processor.

26. The infusion pump of claim 24 further comprising a graphic user interface operatively coupled to the controller.

27. The infusion pump of claim 26 wherein the graphic user interface comprises a touch sensitive screen.

28. The infusion pump of claim 5 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent for delivery to a patient.

29. The infusion pump of claim 28 wherein the first therapeutic agent comprises a fast acting insulin compound and the second therapeutic agent comprises a slow acting insulin compound.

30. The infusion pump of claim 5 wherein the delivery mechanism comprises a plurality of outlet ports and wherein the drive mechanism is configured to impart controlled axial movement on the spool and translate the variable volume of the spool from each of the inlet ports to each of the plurality of outlet ports.

31. The infusion pump of claim 5 wherein the drive mechanism is coupled to the spool with a ball and socket coupling.

32. The infusion pump of claim 5 wherein the drive mechanism comprises a rack and pinion configuration with and end of the rack being coupled to the spool of the delivery mechanism.

33. The infusion pump of claim 5 further comprising a fluid conduit including an inner lumen with a first end of the inner lumen in fluid communication with a patient'"'"'s body and a second end of the inner lumen in fluid communication with the outlet port of the delivery mechanism.

34. An infusion pump for delivering fluids to a patient, comprising:

a disposable component comprising;

a delivery mechanism including;

an axial bore, a first inlet port in fluid communication with an interior volume of the axial bore, a second inlet port axially spaced from the first inlet port and in fluid communication with the interior volume of the axial bore, and at least one outlet port which is axially spaced from the inlet ports and which is in fluid communication with the interior volume of the axial bore, and

a spool which is disposed within the axial bore, which is axially translatable within the axial bore, and which forms a constrained variable volume in conjunction with an interior surface of the axial bore;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a reusable component comprising a drive mechanism which is operatively coupled to the spool, which is configured to impart controlled axial movement on the spool and translate the constrained variable volume from each of the inlet ports to the at least one outlet port and which is configured to expand or contract the constrained variable volume of the spool by exerting translational axial force through a boundary section of the constrained variable volume.

35. The infusion pump of claim 34 wherein the drive mechanism is detachably coupled to the spool.

36. The infusion pump of claim 34 wherein the reusable component further comprises a controller operatively coupled to the drive mechanism.

37. The infusion pump of claim 34 wherein the reusable component further comprises a power storage cell operatively coupled to the drive mechanism.

38. The infusion pump of claim 37 wherein the power storage cell comprises a battery.

39. The infusion pump of claim 34 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent different from the first therapeutic agent for delivery to a patient.

40. The infusion pump of claim 39 wherein the first therapeutic agent comprises insulin.

41. The infusion pump of claim 40 wherein the first therapeutic agent comprises a first type of insulin and the second therapeutic agent comprises a second type of insulin different from the first type.

42. A method of delivering fluid to a patient from two independent fluid reservoirs, comprising:

providing an infusion pump, comprising;

a delivery mechanism including;

a first inlet port,

a second inlet port spaced from the first inlet port,

at least one outlet port which is spaced from the first inlet port and second inlet port, and

a constrained variable volume translatable between a position in fluid communication with the first inlet port, a position in fluid communication with the second inlet port and a position in fluid communication with an outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the constrained variable volume, which is configured to axially translate the constrained variable volume from each of the inlet ports to an outlet port and which is configured to expand or contract the constrained variable volume of the spool;

initiating a dispense cycle by translating the constrained variable volume into a position in fluid communication with the first inlet port;

exerting translational force through a boundary section of the constrained variable volume to expand the constrained variable volume and draw fluid into the constrained variable through the first inlet port from the first reservoir;

translating the constrained variable volume into a position in fluid communication with an outlet port;

exerting translational force through a boundary section of the constrained variable volume so as to at least partially contract the constrained variable volume and dispense fluid from the constrained variable volume through the outlet port to a patient;

translating the constrained variable volume to a position in fluid communication with the second inlet port;

exerting translational force through a boundary section of the constrained variable volume to expand the constrained variable volume and draw fluid into the constrained variable through the second inlet port from the second reservoir;

translating the constrained variable volume to a position in fluid communication with an outlet port; and

exerting translational force through a boundary section of the constrained variable volume so as to at least partially contract the constrained variable volume and dispense fluid from the constrained variable volume through the outlet port to a patient.

43. The method of claim 42 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent different from the first therapeutic agent for delivery to a patient and further comprising delivering a first therapeutic agent and a second therapeutic agent different from the first therapeutic agent to a patient.

44. The method of claim 42 wherein the infusion pump comprises at least three inlet ports and respective fluid reservoirs and further comprising:

translating the constrained variable volume to a position in fluid communication with a third inlet port;

exerting translational force through a boundary section of the constrained variable volume to expand the constrained variable volume and draw fluid into the constrained variable through the third inlet port from a third reservoir;

translating the constrained variable volume to a position in fluid communication with an outlet port; and

exerting translational force through a boundary section of the constrained variable volume so as to at least partially contract the constrained variable volume and dispense fluid from the constrained variable volume through the outlet port to a patient.

45. An infusion pump cartridge for delivering fluid to a patient, comprising:

a delivery mechanism including;

a first delivery section which includes a first inlet port and a first outlet port,

a first constrained variable volume which is translatable between a position in fluid communication with the first inlet port and a position in fluid communication with the first outlet port and which is configured to expand while in fluid communication with the first inlet port and contract while in fluid communication with the first outlet port,

a second delivery section which includes a second inlet port and a second outlet port, and

a second constrained variable volume which is coupled to the first constrained variable volume, which is translatable between a position in fluid communication with the second inlet port and a position in fluid communication with the second outlet port and which is configured to expand while in fluid communication with the second inlet port and contract while in fluid communication with the second outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port; and

a second fluid reservoir including an interior volume in fluid communication with the second inlet port.

46. The infusion pump cartridge of claim 45 wherein the first constrained variable volume is configured to expand or contract due to exertion of a translational force through a boundary section of the first constrained variable volume and the second constrained variable volume is configured to expand or contract due to exertion of a translational force through a boundary section of the second constrained variable volume.

47. An infusion pump, comprising:

a delivery mechanism including;

a first delivery section which includes a first inlet port and a first outlet port,

a first constrained variable volume which is translatable between a position in fluid communication with the first inlet port and a position in fluid communication with the first outlet port,

a second delivery section which includes a second inlet port and a second outlet port, and

a second constrained variable volume which is translatable between a position in fluid communication with the second inlet port and a position in fluid communication with the second outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the first constrained variable volume and operatively coupled to the second constrained variable volume.

48. The infusion pump of claim 47 wherein the drive mechanism is:

configured to translate the first constrained variable volume between the first inlet port and first outlet port,

configured to expand the first constrained variable volume while in fluid communication with the first inlet port and contract the first constrained variable volume while in fluid communication with the first outlet,

configured to translate the second constrained variable volume between the second inlet port and second outlet port, and

configured to expand the second constrained variable volume while in fluid communication with the second inlet port and contract the second constrained variable volume while in fluid communication with the second outlet port.

49. The infusion pump of claim 48 wherein the drive mechanism is configured to expand or contract the first constrained variable volume by exerting translational force through a boundary section of the first constrained variable volume and configured to expand or contract the second constrained variable volume by exerting translational force through a boundary section of the second constrained variable volume.

50. An infusion pump for delivering fluids to a patient, comprising:

a disposable component comprising;

a delivery mechanism including;

a first delivery section which includes a first inlet port and a first outlet port,

a first constrained variable volume which is translatable between a position in fluid communication with the first inlet port and a position in fluid communication with the first outlet port,

a second delivery section which includes a second inlet port and a second outlet port, and

a second constrained variable volume which is translatable between a position in fluid communication with the second inlet port and a position in fluid communication with the second outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a reusable component comprising a drive mechanism which is operatively coupled to the first constrained variable volume and operatively coupled to the second constrained variable volume.

51. The infusion pump of claim 50 wherein the reusable component further comprises a controller operatively coupled to the drive mechanism.

52. The infusion pump of claim 50 wherein the reusable component further comprises a power storage cell operatively coupled to the drive mechanism.

53. The infusion pump of claim 52 wherein the power storage cell comprises a battery.

54. The infusion pump of claim 50 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent different from the first therapeutic agent for delivery to a patient.

55. The infusion pump of claim 54 wherein the first therapeutic agent comprises insulin.

56. The infusion pump of claim 55 wherein the first therapeutic agent comprises a first type of insulin and the second therapeutic agent comprises a second type of insulin different from the first type.

57. An infusion pump, comprising:

a delivery mechanism including;

a first axial bore section which includes a first inlet port and a first outlet port in fluid communication with an interior volume of the first axial bore section,

a first constrained variable volume with a maximum axial length less than a distance between the first inlet port and first outlet port,

a second axial bore section which includes a second inlet port and second outlet port in fluid communication with an interior volume of the second axial bore section, and

a second constrained variable volume with a maximum axial length less than a distance between the second inlet port and second outlet port;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the first constrained variable volume and which is operatively coupled to the second constrained variable volume.

58. The infusion pump of claim 57 wherein the drive mechanism is:

configured to axially translate the first variable volume between the first inlet port and first outlet port,

configured to expand the first constrained variable volume while in fluid communication with the first inlet port and contract the first constrained variable volume while in fluid communication with the first outlet port,

configured to axially translate the second variable volume between the second inlet port and second outlet port, and

configured to expand the second constrained variable volume while in fluid communication with the second inlet port and contract the second constrained variable volume while in fluid communication with the second outlet port.

59. The infusion pump of claim 58 wherein the drive mechanism is configured to expand or contract the first variable volume by exerting translational axial force through a boundary section of the first variable volume and configured to expand or contract the second variable volume by exerting translational axial force through a boundary section of the second variable volume.

60. An infusion pump, comprising:

a delivery mechanism including;

an axial bore including;

a first axial bore section which includes a first inlet port and a first outlet port with said ports being in fluid communication with an interior volume of the first axial bore section,

a second axial bore section which includes a second inlet port and second outlet port with said ports being in fluid communication with an interior volume of the second axial bore section, and

a spool which is disposed within the axial bore, which is axially translatable within the axial bore, and which comprises;

a first spool section including a proximal end configured to couple to a drive mechanism and a first seal which forms a fluid tight seal between the first spool section and an interior surface of the axial bore and which is axially fixed relative to the first spool section and slidable relative to the interior surface of the axial bore,

a second spool section including a proximal end coupled to a distal end of the first spool section by a limited displacement coupling and a second seal which forms a fluid tight seal between the second spool section and the interior surface of the axial bore and which is axially fixed relative to the second spool section and slidable relative to the interior surface of the axial bore,

a third spool section including a proximal end coupled to a distal end of the second spool section by a limited displacement coupling and a third seal which forms a fluid tight seal between the third spool section and the interior surface of the axial bore and which is axially fixed relative to the third spool section and axially slidable relative to the interior surface of the axial bore,

a first constrained variable volume formed between the first spool section, the second spool section, the first seal, the second seal and the interior surface of the axial bore;

a second constrained variable volume formed between the second spool section, the third spool section, the second seal, the third seal and the interior surface of the axial bore;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the proximal end of the spool.

61. The infusion pump of claim 60 wherein the drive mechanism is:

configured to axially translate the first constrained variable volume between the first inlet port and first outlet port,

configured to expand the first constrained variable volume while in fluid communication with the first inlet port and contract the first constrained variable volume while in fluid communication with the first outlet port,

configured to axially translate the second variable volume between the second inlet port and second outlet port, and

configured to expand the second constrained variable volume while in fluid communication with the second inlet port and contract the second constrained variable volume while in fluid communication with the second outlet port.

62. The infusion pump of claim 61 wherein the drive mechanism is configured to expand or contract the first constrained variable volume by exerting translational axial force through a boundary section of the first constrained variable volume and configured to expand or contract the second constrained variable volume by exerting translational axial force through a boundary section of the second constrained variable volume.

63. The infusion pump of claim 60 wherein the first and second seals are axially translatable relative to each other but mechanically constrained to a maximum and minimum axial separation over a limited axial distance by the limited displacement coupling operatively coupled between the first spool section and second spool section.

64. The infusion pump of claim 60 wherein the second and third seals are axially translatable relative to each other but mechanically constrained to a maximum and minimum axial separation over a limited axial distance by the limited displacement coupling operatively coupled between the second spool section and third spool section.

65. The infusion pump of claim 60 wherein the drive mechanism and spool are configured to translate the spool without the first constrained variable volume overlapping the second axial bore section or the second constrained variable volume overlapping the first axial bore section.

66. The infusion pump of claim 60 wherein the first axial bore section comprises a plurality of first inlet ports in fluid communication with the first fluid reservoir and the delivery mechanism is configured such that the first constrained variable volume is positionable to overlap all of the plurality of first inlet ports of the first fluid reservoir independent of an overlap with an inlet port in fluid communication with another fluid reservoir.

67. The infusion pump of claim 60 wherein the second axial bore section comprises a plurality of second inlet ports in fluid communication with the second fluid reservoir and the delivery mechanism is configured such that the second constrained variable volume is positionable to overlap all of the plurality of second inlet ports of the second fluid reservoir independent of an overlap with an inlet port in fluid communication with another fluid reservoir.

68. The infusion pump of claim 60 further comprising a proximal bore seal and a distal bore seal disposed between an outside surface of the spool and an inside surface of the bore at respective proximal and distal ends of the spool, the bore seals being configured to isolate the inlet and outlet ports of the bore from the surrounding environment.

69. The infusion pump of claim 60 wherein the first and second fluid reservoirs comprise collapsible reservoirs bounded by a thin flexible fluid tight material.

70. The infusion pump of claim 69 further comprising a substantially rigid fluid tight shell disposed about the first and second fluid reservoirs with a fluid tight interior volume being formed between an inside surface of the rigid shell and respective outside surfaces of the first and second fluid reservoirs.

71. The infusion pump of claim 70 wherein the interior volume of the rigid shell comprises a vented volume and further comprising a vent port in fluid communication between the interior volume of the bore and an interior volume of the vented volume and a vent outlet port in fluid communication between an interior volume of the bore and the ambient atmosphere.

72. The infusion pump of claim 71 further comprising a pressure sensor disposed in operative fluid communication with the vented volume.

73. The infusion pump of claim 60 further comprising a controller operatively coupled to the drive mechanism.

74. The infusion pump of claim 73 wherein the controller comprises at least one processor and a memory device operatively coupled to the processor.

75. The infusion pump of claim 73 further comprising a graphic user interface operatively coupled to the controller.

76. The infusion pump of claim 75 wherein the graphic user interface comprises a touch sensitive screen.

77. The infusion pump of claim 60 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent for delivery to a patient.

78. The infusion pump of claim 77 wherein the first therapeutic agent comprises a fast acting insulin compound and the second therapeutic agent comprises a slow acting insulin compound.

79. An infusion pump, comprising:

a delivery mechanism including;

an axial bore including;

a first axial bore section which includes a first inlet port and a first outlet port with said first inlet and first outlet ports being in fluid communication with an interior volume of the first axial bore section,

a second axial bore section which is axially spaced from the first axial bore section and which includes a second inlet port and second outlet port with said second inlet and outlet ports being in fluid communication with an interior volume of the second axial bore section, and

a spool which includes a proximal end and a distal end, which is disposed within the axial bore, which is axially translatable within the axial bore, which forms a first constrained variable volume between a first seal axially fixed relative to the spool, a slidable second seal disposed distally of the first seal, and an interior surface of the axial bore and which forms a second constrained variable volume between a third slidable seal disposed distally of the second slidable seal, a fourth seal disposed distally of the third slidable seal and axially fixed relative to the spool and an interior surface of the axial bore;

a first fluid reservoir including an interior volume in fluid communication with the first inlet port;

a second fluid reservoir including an interior volume in fluid communication with the second inlet port; and

a drive mechanism which is operatively coupled to the proximal end of the spool.

80. The infusion pump of claim 79 wherein the second slidable seal and third slidable seal are configured to slide over a slide portion of the spool, the slidable seals forming a substantially fluid tight but displaceable seal between an outside surface of a respective slide portion of the spool and the inside surface of the bore and configured to have a greater frictional resistance to sliding against the inside surface of the bore relative to the frictional resistance to sliding against the slide portion of the spool.

81. The infusion pump of claim 80 wherein the slide portions of the spool comprise smooth reduced diameter axial sections of a shaft of the spool, the reduced diameter sections having a substantially continuous transverse cross section, a first stop at an end of the slide portion which is configured to limit axial movement of the slidable seals over the slide portion and a second stop opposite the first stop that is also configured to limit axial movement of the slidable seals over the slide portion and define relative constrained variable volumes.

82. The infusion pump of claim 79 wherein a shaft of the spool is axially continuous and rigid along an axial direction and the drive mechanism is directly coupled to the proximal end of the rigid shaft.

83. The infusion pump of claim 79 wherein the drive mechanism is:

configured to axially translate the first constrained variable volume between the first inlet port and first outlet port,

configured to expand the first constrained variable volume while in fluid communication with the first inlet port and contract the first constrained variable volume while in fluid communication with the first outlet port,

configured to axially translate the second variable volume between the second inlet port and second outlet port, and

configured to expand the second constrained variable volume while in fluid communication with the second inlet port and contract the second constrained variable volume while in fluid communication with the second outlet port.

84. The infusion pump of claim 80 wherein the drive mechanism is configured to expand or contract the first constrained variable volume by exerting translational axial force through a boundary section of the first constrained variable volume and configured to expand or contract the second constrained variable volume by exerting translational axial force through a boundary section of the second constrained variable volume.

85. The infusion pump of claim 81 wherein the first and second seals are axially translatable relative to each other but mechanically constrained to a maximum and minimum axial separation over a limited axial distance by the stops that confine the second seal.

86. The infusion pump of claim 81 wherein the third and fourth seals are axially translatable relative to each other but mechanically constrained to a maximum and minimum axial separation over a limited axial distance by the stops that confine the third seal.

87. The infusion pump of claim 79 wherein the drive mechanism and spool are configured to translate the spool without the first constrained variable volume overlapping the second axial bore section or the second constrained variable volume overlapping the first axial bore section.

88. The infusion pump of claim 79 wherein the first axial bore section comprises a plurality of first inlet ports in fluid communication with the first fluid reservoir and the delivery mechanism is configured such that the first constrained variable volume is positionable to overlap all of the plurality of first inlet ports of the first fluid reservoir independent of an overlap with an inlet port in fluid communication with another fluid reservoir.

89. The infusion pump of claim 79 wherein the second axial bore section comprises a plurality of second inlet ports in fluid communication with the second fluid reservoir and the delivery mechanism is configured such that the second constrained variable volume is positionable to overlap all of the plurality of second inlet ports of the second fluid reservoir independent of an overlap with an inlet port in fluid communication with another fluid reservoir.

90. The infusion pump of claim 79 further comprising a proximal bore seal and a distal bore seal disposed between an outside surface of the spool and an inside surface of the bore at respective proximal and distal ends of the spool, the bore seals being configured to isolate the inlet and outlet ports of the bore from the surrounding environment.

91. The infusion pump of claim 79 wherein the first and second fluid reservoirs comprise collapsible reservoirs bounded by a thin flexible fluid tight material.

92. The infusion pump of claim 91 further comprising a substantially rigid fluid tight shell disposed about the first and second fluid reservoirs with a fluid tight interior volume being formed between an inside surface of the rigid shell and respective outside surfaces of the first and second fluid reservoirs.

93. The infusion pump of claim 92 wherein the interior volume of the rigid shell comprises a vented volume and further comprising a vent port in fluid communication between the interior volume of the bore and an interior volume of the vented volume and a vent outlet port in fluid communication between an interior volume of the bore and the ambient atmosphere.

94. The infusion pump of claim 93 further comprising a pressure sensor disposed in operative fluid communication with the vented volume.

95. The infusion pump of claim 79 further comprising a controller operatively coupled to the drive mechanism.

96. The infusion pump of claim 95 wherein the controller comprises at least one processor and a memory device operatively coupled to the processor.

97. The infusion pump of claim 95 further comprising a graphic user interface operatively coupled to the controller.

98. The infusion pump of claim 97 wherein the graphic user interface comprises a touch sensitive screen.

99. The infusion pump of claim 79 wherein the first fluid reservoir contains a first therapeutic agent for delivery to a patient and the second fluid reservoir contains a second therapeutic agent for delivery to a patient.

100. The infusion pump of claim 99 wherein the first therapeutic agent comprises a fast acting insulin compound and the second therapeutic agent comprises a slow acting insulin compound.

101. An elastomeric annular seal, comprising an annular seal element which includes a substantially uniform cross section along a circumference thereof, the seal element including a first annular ring element and a second annular ring disposed axially adjacent the first ring with the first and second rings being conjoined or fused by a reduced thickness web therebetween so as to form an inner annular channel and an outer annular channel between the rings.

102. The annular seal of claim 101 wherein an axis of the first ring element and an axis of the second ring element are separated by a distance equal to about 55 percent to about 70 percent of a transverse dimension of the first and second ring elements.

103. The annular seal of claim 101 wherein the seal is molded in a continuous monolithic structure from a single material.

104. The annular seal of claim 103 wherein the seal comprises a polymer.

105. The annular seal of claim 104 wherein the seal comprises Nitrile®

polymer.

106. The annular seal of claim 101 wherein the seal element comprises a polymer including a shore hardness of about 65 shore A to about 75 shore A.

107. The annular seal of claim 101 wherein the seal has an outer diameter of about 2.0 mm to about 10.0 mm.

108. The annular seal of claim 101 wherein the seal element comprises a transverse thickness of about 0.5 mm to about 1.0 mm.