Conductive polymer materials and applications thereof including monitoring and providing effective therapy

• US 20040254513A1
• Filed: 01/19/2004
• Published: 12/16/2004
• Est. Priority Date: 04/10/2002
• Status: Abandoned Application

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Marcquenski, Dan F. Jr., Jensen, Jan, Wariar, Ramesh, Shang, Sherwin, Lamberson, George, Kuhn, David, Lasso, Angel, Castellanos, Raf
• Application Number:
  US10/760,849
• Publication Number:
  US 20040254513A1
• Time in Patent Office: Days
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/0233 Conductive materials, e.g. antistatic coatings for spark prevention
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: F16L 25/01 : specially adapted for realising electrical conduction between the two pipe ends of the joint or between parts thereof
• CPC Class Codes: G01N 27/07 : Construction of measuring vessels; Electrodes therefor
• CPC Class Codes: G01N 27/10 : Investigation or analysis specially adapted for controlling or monitoring operations or for signalling
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

Conductive materials and devices, apparatuses, systems and methods that employ same. The conductive material can include a conductive polymer material that can be utilized to monitor one or a combination of conditions during patient therapy, such as patient access, solution compounding and the like. This can facilitate the safe and effective administration of patient therapy, such as dialysis therapy.

Claims

1. A conductive material comprising a conductive polymer component electrically sensitive to a condition change when in contact with a solution used during dialysis therapy.

2. The conductive material of claim 1, wherein the conductive polymer component includes a polymer matrix and a conductive component that is incorporated in the polymer matrix.

3. The conductive material of claim 2, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

4. The conductive material of claim 2, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

5. The conductive material of claim 2, wherein the conductive component includes greater than about 10% by weight of the conductive material.

6. The conductive material of claim 2, wherein the conductive component is uniformly dispersed throughout the polymer matrix.

7. The conductive material of claim 2, wherein the conductive component includes a conductive fiber material that has an aspect ratio ranging from about 2:

1 to about 30;

1.

8. The conductive material of claim 1, wherein the conductive polymer component is selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

9. The conductive material of claim 1, wherein the condition change relates to a change in impedance due to patient access disconnection during dialysis.

10. The conductive material of claim 1, wherein the condition change relates to a change in conductivity based on a change in pH level of the solution administered during dialysis.

11. A coupler comprising a conductive polymer material that is so constructed and arranged to join tubing.

12. The coupler of claim 11, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophenes, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

13. The coupler of claim 11, wherein the conductive polymer material includes a polymer matrix and a conductive component incorporated within the polymer matrix, and wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

14. The coupler of claim 13, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

15. The coupler of claim 11, wherein the coupler has a generally cylindrical shape with a first opening and a second opening through which tubing can be joined.

16. The coupler of claim 15, wherein the coupler includes an extrudable product.

17. The coupler of claim 15, wherein the coupler includes a member that extends from at least a portion of an inner surface of the coupler allowing a length of a tubing joint that is formed with the coupler and tubing to be pre-set.

18. The coupler of claim 17, wherein the coupler includes an injection moldable product.

19. A sensor apparatus comprising an electrode including a conductive polymer material.

20. The sensor apparatus of claim 19, wherein the conductive polymer material includes a polymer matrix and a conductive component wherein the conductive component is incorporated in the polymer matrix.

21. The sensor apparatus of claim 20, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

22. The sensor apparatus of claim 21, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

23. The sensor apparatus of claim 19, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

24. The sensor apparatus of claim 19, wherein the electrode is attached to a tube member through which fluid flows.

25. The sensor apparatus of claim 19, wherein the tube member is selected from the group consisting of polyvinyl chloride, a non-polyvinyl chloride material and combinations thereof.

26. The sensor apparatus of claim 25, wherein the tube member and the electrode are attached via an attachment mechanism selected from the group consisting of solvent bonding, heating, laser welding, and radio frequency sealing.

27. The sensor apparatus of claim 19, wherein the electrode and at least a portion of the tube member attached to the electrode are secured to a device that has a hub design.

28. The sensor apparatus of claim 27, wherein the hub design includes a housing within which the electrode can be secured.

29. The sensor apparatus of claim 27, wherein the hub design includes a base member against which the electrode can be secured.

30. The sensor apparatus of claim 19 further comprising a controller in electrical contact with the electrode allowing detection of a condition change selected from the group consisting of detection of a change in impedance as the fluid flows through the tube member, detection of a change in conductivity based on a change in pH of the fluid as the fluid flows through the tube member, and combinations thereof.

31. The sensor apparatus of claim 19, wherein the electrode is formed into a dialyzer header.

32. An apparatus for detecting dislodgment of an access device inserted into a patient during medical therapy, the apparatus comprising:

a blood circuit connecting the patient to an extracorporeal blood system wherein the blood circuit includes a blood tubing set having a first tube member connected to a first access device and a second tube member connected to a second access device and wherein the first access device and the second access device are each insertable within the patient such that blood flows between the patient and the extracorporeal blood system via the blood circuit;

a first electrode and a second electrode in fluid contact with the blood and spaced apart from the first access device and the second access device, respectively, wherein at least one of the first electrode and the second electrode includes a conductive polymer material; and

a controller in electrical contact with each of the first electrode and the second electrode wherein the apparatus is capable of detecting a change in impedance in response to dislodgment of at least one of the first access device and the second access device.

33. The apparatus of claim 32, further comprising at least one additional electrode.

34. The apparatus of claim 32, wherein the conductive polymer material includes a polymer matrix and a conductive component that is incorporated in the polymer matrix.

35. The apparatus of claim 34, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

36. The apparatus of claim 34, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof, and mixtures thereof.

37. The apparatus of claim 32, wherein the medical therapy includes dialysis treatment selected from the group consisting of hemodialysis, hemodiafiltration, hemofiltration, continuous renal replacement therapy and home hemodialysis.

38. The apparatus of claim 32, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

39. An apparatus for monitoring delivery of a solution to a patient via an access device insertable within the patient during medical therapy, the apparatus comprising:

a tube member connecting the patient to a fluid system from which the solution flows into the patient via the access device;

an electrode connected to the tube member, wherein the electrode includes a conductive polymer material; and

a controller in electrical contact with the electrode allowing detection of a change in conductivity associated with the solution.

40. The apparatus of claim 39, wherein the conductive polymer material includes a polymer matrix and a conductive component that is incorporated in the polymer matrix.

41. The apparatus of claim 40, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

42. The apparatus of claim 40, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

43. The apparatus of claim 39, wherein the fluid system includes a plurality of solution components that are mixed to form the solution.

44. The apparatus of claim 43, wherein the detection of the change in conductivity is based on a change in pH associated with the solution.

45. The apparatus of claim 44, wherein the solution components have a varying pH level.

46. The apparatus of claim 45, wherein the solution components have a pH that ranges from about 1.8 to about 9.2.

47. The apparatus of claim 45, wherein the solution is monitored to determine whether the pH level of the solution is maintained at a physiological acceptable level after mixing of the solution components and prior to use as a dialysis solution.

48. The apparatus of claim 47, further comprising one or more additional electrodes for monitoring patient access conditions during dialysis therapy.

49. The apparatus of claim 43, wherein the solution components are mixed within a multiple-chamber solution bag to form a dialysis solution.

50. The apparatus of claim 43, wherein the solution components are separately contained in a respective solution bag prior to mixing to form a dialysis solution.

51. The apparatus of claim 39, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethlenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

52. A system for detecting dislodgment of an access device inserted into a patient during medical therapy, the system comprising:

a blood circuit connecting the patient to an extracorporeal blood system wherein the blood circuit includes a blood tubing set having a first tube member connected to a first access device and a second tube member connected to a second access device and wherein the first access device and the second access device are each insertable within the patient such that blood flows between the patient and the extracorporeal blood system via the blood circuit;

a first electrode and a second electrode in fluid contact with the blood and spaced apart from the first access device and the second access device, respectively, wherein at least one of the first electrode and the second electrode includes a conductive polymer material; and

a controller in electrical contact with each of the first electrode and the second electrode capable of detecting a change in impedance in response to dislodgment of at least one of the first access device and the second access device.

53. The system of claim 52 further comprising at least one additional electrode.

54. The system of claim 52 wherein the conductive polymer material includes a polymer matrix and a conductive component that is incorporated in the polymer matrix.

55. The system of claim 54, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof.

56. The system of claim 54, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

57. The sensor apparatus of claim 52, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene)s and mixtures thereof.

58. The system of claim 57, wherein the medical therapy includes dialysis treatment selected from the group consisting of hemodialysis, hemodiafiltration, hemofiltration, continuous renal replacement therapy and home hemodialysis.

59. A system for monitoring delivery of a solution to a patient via an access device insertable within the patient during medical therapy, the system comprising:

a tube member connecting the patient to a fluid system from which the solution flows into the patient via the access device;

an electrode connected to the tube member, wherein the electrode includes a conductive polymer material; and

a controller in electrical contact with the electrode allowing detection of a change in conductivity associated with the solution.

60. The system of claim 59, wherein the conductive polymer material includes a polymer matrix and a conductive component that is incorporated in the polymer matrix.

61. The system of claim 60, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene, and mixtures thereof.

62. The system of claim 60, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

63. The system of claim 59, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

64. The system of claim 63, wherein the fluid system includes a plurality of solution components that are mixed to form the solution.

65. The system of claim 64, wherein the solution components have a varying pH level.

66. The system of claim 65, wherein a pH of the solution components can vary between about 1.8 to about 9.2.

67. The system of claim 65, wherein the change in conductivity is based on a change in a pH of the solution.

68. The system of claim 67, wherein the change in the pH is monitored to determine whether the pH of the solution is maintained at physiological acceptable level prior to use.

69. The system of claim 66, further comprising one or more additional electrodes for monitoring patient access conditions based on a change in impedance in response to dislodgment of the access device.

70. The system of claim 59, wherein the solution is selected from the group consisting of a dialysis solution, a peritoneal dialysis solution, a nutritional solution, a blood solution, an intravenous solution, and combinations thereof.

71. A method of detecting dislodgment of an access device during dialysis, the method comprising:

connecting a patient to a blood circuit having a pair of electrodes each coupled to a blood circuit in fluid contact with blood that flows through the blood circuit wherein at least one of the electrodes includes a conductive polymer material;

passing an electrical signal through the blood via the pair of electrodes thereby defining a loop along which an impedance can be measured; and

detecting a disconnection between the patient and the blood circuit in response to a change in the impedance.

72. The method of claim 71, wherein the conductive polymer material includes a polymer matrix and a conductive component incorporated within the polymer matrix.

73. The method of claim 72, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and combinations thereof.

74. The method of claim 71, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

75. The method of claim 71, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene)s and mixtures thereof.

76. A method of monitoring delivery of a solution to a patient during medical therapy, the method comprising:

connecting a patient to a tube member through which the solution can flow to the patient via an access device wherein the tube member has an electrode attached thereto, the electrode including a conductive polymer material;

passing an electrical signal into the solution via the electrode thereby allowing a conductivity associated with the solution to be measured; and

detecting a change in conductivity based on a change in pH of the solution.

77. The method of claim 76, wherein the conductive polymer material includes a polymer matrix and a conductive component incorporated within the polymer matrix.

78. The method of claim 77, wherein the polymer matrix is selected from the group consisting of polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and combinations thereof.

79. The method of claim 77, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

80. The method of claim 76, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

81. The method of claim 76, wherein the pH of the solution is monitored to determine whether the pH is maintained at a physiological acceptable level prior to use.

82. The method of claim 76, wherein the solution is derived from a mixture of solution components that have a pH ranging from about 1.8 to about 9.2.

83. The method of claim 76, further comprising one or more additional electrodes that are connected to the tube member such that a change in impedance based on dislodgement of the access device can be monitored.