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

• US 8,920,356 B2
• Filed: 06/30/2011
• Issued: 12/30/2014
• Est. Priority Date: 04/10/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Shang, Sherwin, Wariar, Ramesh, Lasso, Angel, Lamberson, George, Marcquenski, Dan F. Jr., Jensen, Jan, Kuhn, David, Castellanos, Raf
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/173,828
• Publication Number:
  US 20110264042A1
• Time in Patent Office: 1,279 Days
• Field of Search: 210/645, 210/739, 210/646, 604/5.04, 604/6.09, 604/6.11, 604/6.16, 604/6.06, 604/6.08
• US Class Current: 604/6.08
• 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

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

Claims

1. A medical device configured to detect dislodgement of an access device during medical treatment of a patient, the medical device comprising:

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

an electrode coupled to the blood circuit, and in fluid contact with the blood flowing in the blood circuit, the electrode made of a conductive polymer material including (a) a polymer matrix and a conductive component uniformly dispersed throughout the polymer matrix, wherein the polymer matrix is selected from the group consisting of acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof, or (b) a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polyethylenedioxthiophene, poly(p-phenylene vinylene) and mixtures thereof;

and

a controller in electrical communication with the electrode and configured to detect a change in an electrical value responsive to dislodgement of the access device as the blood flows between the patient and the extracorporeal blood system connected to the patient via the access device.

2. The medical device of claim 1, wherein the controller is configured to correct for a deviation from a baseline measurement of the electrical value detected within the conductor loop due to variations in the blood during the medical treatment.

3. The medical device according to claim 1, wherein the controller is capable of measuring a change in impedance in response to dislodgement of the access device.

4. The medical device of claim 1, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

5. The medical device of claim 1, further including a coupler incorporated into a portion of the tube member so as to be in fluid contact with the blood flowing through the tube member, wherein the coupler includes a member that extends from at least a portion of an inner surface of the coupler and acts as a stop for a first and second portion of the tube member, thereby allowing a length of a tubing joint that is formed with the coupler and the tube member to be pre-set.

6. The medical device of claim 5, wherein the coupler is injection molded.

7. The medical device of claim 5, wherein the coupler is at least one of solvent bondable, heat sealable, laser weldable, and radio frequency sealable to the tube member.

8. The medical device of claim 5, further including a holding device that includes (i) a base member having a conductive base portion and (ii) an arm member pivotally attached to the base member, the coupler securely positioned between the arm member and the base member of the holding device.

9. The medical device of claim 1, wherein the access device is selected from the group consisting of a needle, a venous needle, and a catheter.

10. A medical device configured to detect dislodgement of an access device during medical treatment, the medical device 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 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; and

first and second electrodes coupled to the first and second tube members, respectively, and in fluid contact with the blood flowing in the blood circuit, wherein the first and second electrodes are made of a conductive polymer material including (a) a polymer matrix and a conductive component uniformly dispersed throughout the polymer matrix, wherein the polymer matrix is selected from the group consisting of acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof, or (b) a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene, polvethylenedioxthiophene, poly(p-phenylene vinylene) and mixtures thereof;

wherein the electrodes define a conductor loop that detects a change in an electrical value responsive to dislodgement of at least one of the access devices as the blood flows between the patient and the extracorporeal blood system connected to the patient via the access devices.

11. The medical device of claim 10, further comprising a controller configured to correct for a deviation from a baseline measurement of the electrical value detected within the conductor loop due to variations in the blood during the medical treatment.

12. The medical device according to claim 11, wherein the controller is capable of measuring a change in impedance in response to dislodgement of at least one of the access devices.

13. The medical device of claim 10, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

14. The medical device of claim 10, further including first and second couplers incorporated into a portion of the first and second tube members, respectively, so as to be in fluid contact with the blood flowing through the respective first and second tube members, wherein each coupler includes a member that extends from at least a portion of an inner surface of the coupler and acts as a stop for a first and second portion of the respective tube member, thereby allowing a length of a tubing joint that is formed with the coupler and the respective tube member to be pre-set.

15. The medical device of claim 14, wherein the couplers are injection molded.

16. The medical device of claim 14, wherein the couplers are at least one of solvent bondable, heat sealable, laser weldable, and radio frequency sealable to the tube member.

17. The medical device of claim 14, further including first and second holding devices that each includes (i) a base member having a conductive base portion and (ii) an arm member pivotally attached to the base member, the couplers each securely positioned between the arm member and the base member of the respective holding device.

18. The medical device of claim 10, wherein the first access device and the second access device are selected from the group consisting of a needle, a venous needle, and a catheter.

19. A medical device configured to conduct a medical therapy and to detect an access disconnection during medical therapy, the medical device comprising:

a dialysis machine having one or more connectors including an access device for connecting a patient to the dialysis machine via a blood circuit allowing blood to flow between the patient and the dialysis machine during medical therapy;

an electrode coupled to the blood circuit and in fluid contact with the blood flowing in the blood circuit, the electrode made of a conductive polymer material including (a) a polymer matrix and a conductive component uniformly dispersed throughout the polymer matrix, wherein the polymer matrix is selected from the group consisting of acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof or (b) a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophene,polyethylendioxthiophene,poly(p-phenylene vinylene) and mixtures,thereof;

and

a controller in electrical communication with the electrode and configured to generate an electrical signal that can be passed into the flowing blood via the electrode during the medical therapy.

20. The medical device of claim 19, wherein the access device is selected from the group consisting of a needle, a venous needle, and a catheter.

21. The medical device of claim 19, wherein the dialysis machine is capable of at least one of hemodialysis, hemodiafiltration, hemofiltration, and continuous renal replacement therapy.

22. The medical device of claim 19, wherein the controller is configured to sound an alarm or shut off a blood pump upon disconnection of the access device.

23. The medical device of claim 19, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.

24. The medical device of claim 19, further including a coupler incorporated into a portion of the blood circuit so as to be in fluid contact with the blood flowing through the blood circuit, wherein the coupler includes a member that extends from at least a portion of an inner surface of the coupler and acts as a stop for a first and second portion of the blood circuit, thereby allowing a length of a tubing joint that is formed with the coupler and the blood circuit to be pre-set.

25. The medical device of claim 24, wherein the coupler is injection molded.

26. The medical device of claim 24, wherein the coupler is at least one of solvent bondable, heat sealable, laser weldable, and radio frequency sealable to the tube member.

27. The medical device of claim 24, further including (a) a holding device that includes (i) a base member having a conductive base portion and (ii) an arm member pivotally attached to the base member, the coupler securely positioned between the arm member and the base member of the holding device.

28. A medical device configured to detect dislodgement of an access device during medical treatment of a patient, the medical device comprising:

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

a pair of electrodes coupled to the blood circuit and in fluid contact with the blood flowing in the blood circuit, the electrodes made of a conductive polymer material including (a) a polymer matrix and a conductive component uniformly dispersed throughout the polymer matrix, wherein the polymer matrix is selected from the group consisting of acrylonitrile butadiene styrene, polycarbonate, acrylic, a cyclo olefin copolymer, a cyclo olefin copolymer blend, a metallocene-based polyethylene and mixtures thereof or (b) a conductive polymer component selected from the group consisting of polvaniline, polypyrrole, polythiophene, polvethylenedioxthiophene, polyp-phenylene vinylene) and mixtures thereof;

wherein the electrodes define a conductor loop that detects a change in an electrical value responsive to dislodgement of the access device as the blood flows between the patient and the extracorporeal blood system connected to the patient via the access device.

29. The medical device of claim 28, wherein the conductive component is selected from the group consisting of stainless steel, fillers, carbon black, fibers thereof and mixtures thereof.