Electrokinetic delivery systems, devices and methods

• US 7,517,440 B2
• Filed: 04/21/2005
• Issued: 04/14/2009
• Est. Priority Date: 07/17/2002
• Status: Expired due to Fees

• Current Assignee: Teleflex Life Sciences Pte., Ltd. (Teleflex Incorporated)
• Original Assignee: Eksigent Technologies LLC
• Inventors: Paul, Phillip H., Neyer, David W., Anex, Deon S., Hlavka, Edwin J.
• Primary Examiner(s): Bell; Bruce F
• Application Number:
  US11/112,867
• Publication Number:
  US 20050247558A1
• Time in Patent Office: 1,454 Days
• Field of Search: 204/450, 204/600, 204/263, 204/265, 204/266, 417/48, 137/1, 137/8, 137/10, 137/12, 137/825
• US Class Current: 204/450
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: F04B 19/006 Micropumps F04B43/043 and F04B43/095 take precedence
• CPC Class Codes: F04B 43/043 Micropumps
• CPC Class Codes: Y10T 137/0318 Processes
• CPC Class Codes: Y10T 137/0357 For producing uniform flow
• CPC Class Codes: Y10T 137/0368 By speed of fluid
• CPC Class Codes: Y10T 137/0379 By fluid pressure
• CPC Class Codes: Y10T 137/218 Means to regulate or vary operation of device

Abstract

A method of pumping fluid including the steps of providing an electrokinetic pump comprising a pair of double-layer capacitive electrodes having a capacitance of at least 10⁻² Farads/cm² and being connectable to a power source, a porous dielectric material disposed between the electrodes and a reservoir containing pump fluid; connecting the electrodes to a power source; and moving pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump. The invention also includes an electrokinetic pump system having a pair of double-layer capacitive electrodes having a capacitance of at least 10⁻² Farads/cm²; a porous dielectric material disposed between the electrodes; a reservoir containing pump fluid; and a power source connected to the electrodes; the electrodes, dielectric material and power source being adapted to move the pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump.

Claims

1. A method of pumping fluid comprising:

providing an electrokinetic pump comprising a pair of double-layer capacitive electrodes having a capacitance of at least 10<sup>−

2</sup> Farads/cm² and being connectable to a power source, a porous dielectric material disposed between the electrodes and a reservoir containing pump fluid;

connecting the electrodes to a power source; and

moving pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump.

2. The method of claim 1 wherein the electrodes comprise high microscopic surface area electrodes.

3. The method of claim 1 wherein the moving step further comprises moving the pump fluid out of the reservoir and through a pump outlet.

4. The method of claim 1 wherein the reservoir comprises a first reservoir, the electrokinetic pump further comprising a second reservoir, the moving step comprising moving the pump fluid out of the first reservoir into the second reservoir.

5. The method of claim 4 wherein the electrokinetic pump further comprises a third reservoir and a sampled fluid disposed in the third reservoir, the moving step further comprising moving sampled fluid through a pump inlet into the third reservoir as the pump fluid moves from the first reservoir into the second reservoir.

6. The method of claim 4 wherein the electrokinetic pump further comprises a third reservoir and a dispensed fluid disposed in the third reservoir, the moving step further comprising moving dispensed fluid out of the third reservoir and through a pump outlet as the pump fluid moves from the first reservoir into the second reservoir.

7. The method of claim 6 wherein the step of moving the pump fluid comprises moving the pump fluid at a pump fluid flow rate and the step of moving the dispensed fluid comprises moving the dispensed fluid at a dispensed fluid flow rate, the dispensed fluid flow rate being between about 0.1 times and 10 times the pump fluid flow rate.

8. The method of claim 6 wherein the providing step comprises providing an electrokinetic pump having a volume no greater than 250% of an initial volume of dispensed fluid.

9. The method of claim 6 wherein the third reservoir comprises a syringe, the moving step further comprising moving the dispensed fluid out of the syringe and into a patient as the pump fluid moves from the first reservoir into the second reservoir.

10. The method of claim 9 further comprising adding dispensed fluid to the syringe prior to the moving step.

11. The method of claim 6 wherein the third reservoir comprises a collapsible container, the moving step further comprising moving the dispensed fluid out of the collapsible container and into a patient as the pump fluid moves from the first reservoir into the second reservoir.

12. The method of claim 6 wherein the electrokinetic pump comprises a first electrokinetic pump and the moving step comprises moving dispensed fluid into a patient, the method further comprising:

providing a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric material disposed between the electrodes, a first reservoir of pump fluid, a second reservoir, a third reservoir and a dispensed fluid disposed in the third reservoir;

connecting the electrodes of the second electrokinetic pump to a power source;

moving dispensed fluid out of the third reservoir and through a second electrokinetic pump outlet into the patient as pump fluid of the second electrokinetic pump moves from the first reservoir into the second reservoir of the second electrokinetic pump substantially without the occurrence of Faradaic processes in the second pump.

13. The method of claim 12 wherein the step of moving dispensed fluid from the first electrokinetic pump is performed at a first rate and the step of moving dispensed fluid from the second electrokinetic pump is performed at a second rate different than the first rate.

14. The method of claim 12 wherein the dispensed fluid of the first electrokinetic pump and the dispensed fluid of the second electrokinetic pump are the same kind of fluid.

15. The method of claim 12 wherein the dispensed fluid of the first electrokinetic pump and the dispensed fluid of the second electrokinetic pump are different kinds of fluid.

16. The method of claim 6 wherein the electrokinetic pump comprises a first electrokinetic pump and the moving step comprises moving dispensed fluid into a patient, the method further comprising:

providing a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric material disposed between the electrodes, a first reservoir of pump fluid, a second reservoir, a third reservoir and a dispensed fluid disposed in the third reservoir;

connecting the electrodes of the second electrokinetic pump to a power source;

moving dispensed fluid out of the second electrokinetic pump third reservoir and through the pump outlet into the patient as pump fluid of the second electrokinetic pump moves from the first reservoir into the second reservoir of the second electrokinetic pump substantially without the occurrence of Faradaic processes in the second pump.

17. The method of claim 16 wherein the step of moving dispensed fluid from the first electrokinetic pump is performed at a first rate and the step of moving dispensed fluid from the second electrokinetic pump is performed at a second rate different than the first rate.

18. The method of claim 16 wherein the dispensed fluid of the first electrokinetic pump and the dispensed fluid of the second electrokinetic pump are the same kind of fluid.

19. The method of claim 16 wherein the dispensed fluid of the first electrokinetic pump and the dispensed fluid of the second electrokinetic pump are different kinds of fluid.

20. The method of claim 6 wherein the electrokinetic pump comprises a first electrokinetic pump and the moving step comprises moving dispensed fluid into a patient, the method further comprising:

providing a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric material disposed between the electrodes, a first reservoir of pump fluid and a second reservoir;

connecting the electrodes of the second electrokinetic pump to a power source;

moving dispensed fluid out of the third reservoir and through the pump outlet into the patient as pump fluid of the second electrokinetic pump moves from the first reservoir into the second reservoir of the second electrokinetic pump substantially without the occurrence of Faradaic processes in the second pump.

21. The method of claim 6 further comprising determining a patient'"'"'s need for the dispensed fluid, the moving step further comprising dispensing a quantity of the dispensed fluid in response to the determined need.

22. The method of claim 21 wherein the dispensed fluid comprises insulin and the determining step comprises determining the patient'"'"'s blood glucose concentration, the moving step comprising injecting a quantity of insulin into the patient in response to the determined blood glucose concentration.

23. The method of claim 22 wherein the moving step comprises automatically injecting a quantity of insulin into the patient in response to the determined blood glucose concentration.

24. The method of claim 21 wherein the determining step comprises sampling a fluid taken from the patient with a second electrokinetic pump.

25. The method of claim 6 further comprising monitoring a parameter related to an amount of dispensed fluid moved out of the third reservoir during the moving step.

26. The method of claim 25 further comprising using the monitored parameter to provide feedback control of the moving step.

27. The method of claim 26 wherein the monitored parameter is flow rate.

28. The method of claim 26 wherein the monitored parameter is position of a third reservoir pump element.

29. The method of claim 25 further comprising using the monitored parameter to provide an indication related to the dispensed fluid.

30. The method of claim 25 further comprising using the monitored parameter to calculate a desired amount of dispensed fluid to be dispensed.

31. The method of claim 29 wherein the step of using the monitored parameter comprises using the monitored parameter to indicate the presence of an occlusion in the pump outlet.

32. The method of claim 6 wherein the moving step further comprises moving dispensed fluid out of the third reservoir for a fixed time interval to dispense a fixed volume of dispensed fluid.

33. The method of claim 6 further comprising adjusting an amount of dispensed fluid moved out of the third reservoir.

34. The method of claim 6 further comprising loading the dispensed fluid into the third reservoir and treating the electrokinetic pump to alter a characteristic of the dispensed fluid.

35. The method of claim 34 wherein the treating step comprises irradiating the electrokinetic pump.

36. The method of claim 4 further comprising moving pump fluid from the second reservoir to the first reservoir after the first moving step.

37. The method of claim 1 wherein the moving step comprises moving substantially all of the pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump.

38. The method of claim 37 wherein the moving step comprises moving the pump fluid out of the reservoir at a flow rate of less than about 1 microliter/minute and with a steady state flow rate error of no more than about 5% over the entire method step.

39. The method of claim 1 further comprising generating a pump fluid pressure between about 1 and about 1000 psi.

40. The method of claim 1 wherein the electrokinetic pump further comprises a power source connectable to the electrodes and a housing containing the electrodes, dielectric material, reservoir and power source, the electrokinetic pump having a volume of at most about 11 cm³, the moving step further comprising moving at least about 0.2 milliliters of pump fluid.

41. The method of claim 40 wherein the moving step comprises moving the pump fluid at a rate of less than about 10 nanoliters/min.

42. The method of claim 41 wherein the moving step comprises moving the pump fluid substantially continuously for about 30 days.

43. The method of claim 1 further comprising supporting the electrokinetic pump on a patient.

44. The method of claim 43 further comprising implanting the electrokinetic pump in a patient.

45. The method of claim 43 wherein the electrokinetic pump has a shape, the implanting step comprising placing the electrokinetic pump adjacent to an anatomical feature of the patient having a shape complementary to the electrokinetic pump shape.

46. The method of claim 1 wherein the electrokinetic pump comprises a first electrokinetic pump, the moving step comprising moving pump fluid at a first rate into a patient, the method further comprising:

providing a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric material disposed between the electrodes and a reservoir of a pump fluid;

connecting the electrodes of the second electrokinetic pump to a power source; and

moving pump fluid out of the second electrokinetic pump reservoir at a second rate into the patient substantially without the occurrence of Faradaic processes in the second pump.

47. The method of claim 46 wherein the pump fluid of the first electrokinetic pump and the pump fluid of the second electrokinetic pump are the same kind of fluid.

48. The method of claim 46 wherein the pump fluid of the first electrokinetic pump and the pump fluid of the second electrokinetic pump are different kinds of fluid.

49. The method of claim 1 wherein the connecting step comprises connecting the power source to the electrodes in a time modulated manner.

50. The method of claim 1 wherein the connecting step comprises alternating the power source between an on state and an off state.

51. The method of claim 1 wherein the connecting step comprises alternating the power source between a normally off state and a periodic on state in response to a computer program.

52. An electrokinetic pump system comprising:

a pair of double-layer capacitive electrodes having a capacitance of at least 10<sup>−

2</sup> Farads/cm²;

a porous dielectric material disposed between the electrodes;

a reservoir containing pump fluid; and

a power source connected to the electrodes;

the electrodes, dielectric material and power source being adapted to move the pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump.

53. The electrokinetic pump system of claim 52 further comprising a pump outlet, the electrodes, dielectric material and power source being further adapted to move the pump fluid out of the reservoir and through the pump outlet.

54. The electrokinetic pump system of claim 52 wherein the reservoir is a first reservoir, the system further comprising a second reservoir, the electrodes, dielectric material and power source being further adapted to move the pump fluid out of the first reservoir and into the second reservoir.

55. The electrokinetic pump system of claim 54 further comprising a third reservoir containing dispensed fluid and a pump outlet, the electrodes, dielectric material and power source being further adapted to move the dispensed fluid out of the pump outlet as the pump fluid moves from the first reservoir into the second reservoir.

56. The electrokinetic pump system of claim 55 further comprising an indicator adapted to indicate an amount of dispensed fluid present in the third reservoir.

57. The electrokinetic pump system of claim 55 further comprising a controller adapted to control delivery of power from the power source to the electrodes to move a fixed volume of dispensed fluid out of the third reservoir.

58. The electrokinetic pump system of claim 55 further comprising a controller adapted to control delivery of power from the power source to the electrodes to move dispensed fluid for a fixed period of time.

59. The electrokinetic pump system of claim 55 further comprising a controller adapted to control delivery of power from the power source to the electrodes to move dispensed fluid out of the third reservoir at a fixed time interval.

60. The electrokinetic pump system of claim 55 further comprising a controller adapted to control delivery of power from the power source to the electrodes to move an amount dispensed fluid out of the third reservoir in response to a user input.

61. The electrokinetic pump system of claim 55 comprising:

a first electrokinetic pump comprising the electrodes, the first, second and third reservoirs, the pump outlet, the dielectric material and the power source, the pump outlet comprising a first pump outlet, the first electrokinetic pump being adapted to move dispensed fluid into a patient through the first pump outlet;

the system further comprising a second electrokinetic pump comprising a second pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric disposed between the second pair of electrodes, a fourth reservoir containing pump fluid, a second reservoir and a sixth reservoir containing a dispensed fluid, and a second pump outlet, the second electrokinetic pump electrodes and dielectric material being adapted to move the second electrokinetic pump fluid out of the fourth reservoir into the fifth reservoir to move the second electrokinetic pump dispensed fluid through the second pump outlet into the patient when the second electrokinetic pump electrodes are connected to a power source substantially without the occurrence of Faradaic processes in the second pump,

the system further comprising a controller adapted to control the first and second electrokinetic pumps.

62. The electrokinetic pump system of claim 61 wherein the first electrokinetic pump is further adapted move dispensed fluid at a first rate and the second electrokinetic pump is further adapted to move dispensed fluid at a second rate different than the first rate.

63. The electrokinetic pump system of claim 55 comprising:

a first electrokinetic pump comprising the electrodes, the first, second and third reservoirs, the pump outlet, the dielectric material and the power source, the first electrokinetic pump being adapted to move dispensed fluid into a patient;

the system further comprising a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric disposed between the electrodes, a fourth reservoir containing pump fluid, a fifth reservoir and a sixth reservoir containing a dispensed fluid, the second electrokinetic pump electrodes and dielectric material being adapted to move the second electrokinetic pump fluid out of the fourth reservoir into the fifth reservoir to move the second electrokinetic pump dispensed fluid through the pump outlet into the patient when the second electrokinetic pump electrodes are connected to a power source substantially without the occurrence of Faradaic processes in the second pump.

64. The electrokinetic pump system of claim 63 wherein the first electrokinetic pump is further adapted move dispensed fluid at a first rate and the second electrokinetic pump is further adapted to move dispensed fluid at a second rate different than the first rate.

65. The electrokinetic pump system of claim 55 comprising:

a first electrokinetic pump comprising the electrodes, the first, second and third reservoirs, the pump outlet, the dielectric material and the power source, the first electrokinetic pump being adapted to move dispensed fluid into a patient;

the system further comprising a second electrokinetic pump comprising a pair of double-layer capacitive electrodes connectable to a power source, a porous dielectric disposed between the electrodes, a fourth reservoir containing pump fluid and a fifth reservoir, the second electrokinetic pump electrodes and dielectric material being adapted to move the second electrokinetic pump fluid out of the fourth reservoir into the fifth reservoir to move the dispensed fluid through the pump outlet into the patient when the second electrokinetic pump electrodes are connected to a power source substantially without the occurrence of Faradaic processes in the second pump.

66. The electrokinetic pump system of claim 55 further comprising a movable member disposed between the second reservoir and the third reservoir adapted to move as pump fluid moves from the first reservoir into the second reservoir to move the dispensed fluid out of the third reservoir.

67. The electrokinetic pump system of claim 66 wherein the movable member comprises a hydraulic amplifier.

68. The electrokinetic pump system of claim 55 further comprising a sensor adapted to determine a patient'"'"'s need for the dispensed fluid.

69. The electrokinetic pump system of claim 68 further comprising a controller adapted to control delivery of power from the power source to the electrodes in response to a signal from the sensor.

70. The electrokinetic pump system of claim 68 wherein the sensor comprises an electrokinetic pump adapted to sample a fluid from the patient.

71. The electrokinetic pump system of claim 54 further comprising a third reservoir containing a sampled fluid and a pump inlet, the electrodes, dielectric material and power source being further adapted to move the sampled fluid into the pump inlet as the pump fluid moves from the first reservoir into the second reservoir.

72. The electrokinetic pump system of claim 71 further comprising a movable member disposed between the second reservoir and the first reservoir adapted to move as pump fluid moves from the first reservoir into the second reservoir to move the sampled fluid into the third reservoir.

73. The electrokinetic pump system of claim 54 further comprising a third reservoir, an external port communicating with the third reservoir and a movable member disposed between the second reservoir and the third reservoir adapted to change an effective volume of the third reservoir as an effective volume of the second reservoir changes.

74. The electrokinetic pump system of claim 73 further comprising a laminated housing, the electrokinetic pump system having a volume no greater than 250% of the largest effective volume of the third reservoir.

75. The electrokinetic pump system of claim 73 wherein the third reservoir comprises a syringe.

76. The electrokinetic pump system of claim 73 wherein the third reservoir comprises a collapsible container.

77. The electrokinetic pump system of claim 73 further comprising a sensor adapted to monitor a parameter related to an amount of fluid dispensed from the third reservoir.

78. The electrokinetic pump system of claim 77 further comprising a feedback control element adapted to control power delivered to the electrodes by the power source in response to a signal from the sensor.

79. The electrokinetic pump system of claim 78 wherein the parameter is flow rate of fluid dispensed from the third reservoir.

80. The electrokinetic pump system of claim 77 wherein the third reservoir comprises a syringe, the sensor being adapted to monitor a position of the syringe.

81. The electrokinetic pump system of claim 80 wherein the syringe comprises a plunger and a magnet, the sensor comprising a magnetostrictive sensor adapted to detect a position of the magnet.

82. The electrokinetic pump system of claim 80 further comprising a controller adapted to control application of power from the power source to the electrodes in response to a sensor output signal.

83. The electrokinetic pump system of claim 77 further comprising an indicator adapted to provide an indication related to fluid dispensed from the third reservoir.

84. The electrokinetic pump system of claim 83 wherein the indication comprises an occlusion of the external port.

85. The electrokinetic pump system of claim 52 wherein the electrodes, dielectric material and power source are further adapted to move substantially all of the pump fluid out of the reservoir substantially without the occurrence of Faradaic processes in the pump.

86. The electrokinetic pump system of claim 52 wherein the electrodes, dielectric material and power source are further adapted to move substantially all of the pump fluid out of the reservoir at a flow rate of less than about 1 microliter/minute and with a steady state flow rate error of no more than about 5% substantially without the occurrence of Faradaic processes in the pump.

87. The electrokinetic pump system of claim 52 wherein the electrodes, dielectric material and power source are further adapted to generate a pump fluid pressure between about 1 and about 1000 psi.

88. The electrokinetic pump system of claim 52 further comprising a housing having a volume of at most about 11 cm³ and wherein the electrodes, dielectric material and power source are further adapted to move at least about 0.2 milliliters of pump fluid from the reservoir.

89. The electrokinetic pump system of claim 88 wherein the electrodes, dielectric material and power source are further adapted to move pump fluid from the reservoir at a rate of less than 10 nanoliters/min.

90. The electrokinetic pump system of claim 89 wherein the electrodes, dielectric material and power source are further adapted to move pump fluid from the reservoir from the reservoir substantially continuously for about 30 days.

91. The electrokinetic pump system of claim 88 wherein the housing comprises a laminated housing.

92. The electrokinetic pump system of claim 52 wherein the electrodes, dielectric material and power source are further adapted to be implanted in a patient.

93. The electrokinetic pump system of claim 52 further comprising an indicator adapted to indicate an amount of pump fluid present in the reservoir.

94. The electrokinetic pump system of claim 52 further comprising a controller adapted to provide power from the power source to the electrodes in a time modulated manner.

95. The electrokinetic pump system of claim 52 further comprising a controller adapted to alternate the power source between an on state and an off state.

96. The electrokinetic pump system of claim 52 further comprising a controller adapted to alternate the power source between a normally off state and a periodic on state in response to a computer program.

97. The electrokinetic pump system of claim 52 further comprising a housing containing the electrodes, reservoir, dielectric material and power source, the housing being adapted to be worn on a human or animal body.

98. A displacement pump comprising:

a dispensed fluid reservoir;

a pump outlet;

a displacement mechanism;

a power source adapted to operate the displacement mechanism; and

a housing containing the reservoir, pump outlet, power source and displacement mechanism, the housing having a volume no more than 250% of the volume of the dispensed fluid reservoir;

the displacement mechanism and power source being farther adapted to dispense substantially all of dispensed fluid from the reservoir through the pump outlet at a flow rate no more than 1 microliter/minute with a steady state flow rate error of no more than about 5%.

99. The pump of claim 98 wherein the displacement mechanism comprises a movable member.

100. The pump of claim 99 wherein the displacement mechanism further comprises an electrokinetic assembly comprising a pair of electrodes connectable to the power source, a porous dielectric material disposed between the electrodes;

and pump fluid in contact with the electrodes.

101. The pump of claim 100 wherein the electrodes comprise double-layer capacitive electrodes.

102. A pump comprising:

a reservoir of pump fluid;

a pump mechanism operable on the pump fluid;

a pump outlet;

a power source connectable to the pump mechanism to move pump fluid from the reservoir through the pump outlet at a flow rate no more than 1 microliter/minute with a steady state flow rate error of no more than about 5%; and

a housing containing the reservoir, electrodes, pump outlet and power source, the housing having a volume no more than 150% of the volume of the reservoir.

103. The pump of claim 102 wherein the pump mechanism comprises a pair of double-layer capacitive electrodes having a capacitance of at least 10⁻

2 Farads/cm².