Method of direct tissue gas tension measurement and apparatus therefor

• US 4,512,349 A
• Filed: 05/13/1983
• Issued: 04/23/1985
• Est. Priority Date: 05/13/1983
• Status: Expired due to Fees

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Knighton, David R., Hunt, Thomas K., Chang, Ning, Goodson, William H. III, Firmin, Richard, Gottrup, Finn
• Primary Examiner(s): Coven, Edward M.
• Application Number:
  US06/494,173
• Time in Patent Office: 711 Days
• Field of Search: 128/630, 128/632, 128/635, 128/748, 55/158, 55/270
• US Class Current: 600/360
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence

Abstract

A new method of tissue oxygen tension measurement which is suitable for human use utilizes an implanted Silastic tube which is inserted through four to five cm of subcutaneous tissue leaving the ends exposed. With the tube filled, for example, with a saline solution, reference and oxygen electrodes are inserted at the exposed ends and by the use of a polarographic potential the amount of oxygen which permeates through the tube from the tissue into the saline solution may be measured on a continuous real-time basis.

Claims

1. A method of direct tissue gas tension measurement by use of a gas permeable tube implanted in such tissue and by gas polarography comprising the following steps:

implanting a predetermined length of said tube through said tissue and leaving a pair of exposed ends of such tube;

inserting reference and gas electrodes in respective ends of said tube;

filling said tube with an electrolytic fluid;

waiting for said gas to permeate from said tissue through said tube into said fluid;

and applying a polarographic potential between said gas and reference electrodes and measuring the electrical signal from said gas electrode.

2. A method as in claim 1 including the step of calibrating said gas electrode.

3. A method as in claim 2 in which said calibration step is conducted before said tube is implanted.

4. A method as in claim 2 where said calibration step includes placing said tube or an equivalent tube in a water bath, maintaining the water bath at tissue temperature, inserting reference and gas electrodes in the tube ends, applying a polarographic potential across said electrodes, filling said tube with said electrolytic fluid, applying a polarographic potential between said gas and reference electrodes, bubbling in said water bath air allowing it to permeate into said electrolytic fluid within said tube;

measuring the resultant electrical signal from the gas electrode, and utilizing this signal as a maximum level, bubbling nitrogen in said water bath allowing it to permeate into the electrolytic fluid within said tube, measuring the resultant electrical signal from the gas electrode, and utilizing this signal as a zero level.

5. A method as in claim 4 where said electrical signal is measured by an ammeter circuit including the step of regulating said ammeter by utilizing said zero and maximum levels of said calibration step.

6. A method as in claim 1 where said implanting step includes the steps of utilizing a spinal needle with a mandrel which fits within the spinal needle, allowing a portion of the mandrel to extend from the end of the needle opposite that of the sharpened end, and fitting on the extended mandrel and gluing thereon such tube whereby the outer diameter of the tube is matched to the outer diameter of the spinal needle so that insertion of the sharpened end of the needle through the tissue creates a hole in the tissue of the same diameter as said tube.

7. A method as in claim 6 in which said mandrel is maintained in said spinal needle by bending such needle.

8. A method as in claim 6 where after said implantation said spinal needle is cut off from said tube to allow insertion of one of said electrodes.

9. A method as in claim 1 in which said polarographic potential is of a magnitude for producing oxygen.

10. A method as in claim 1 where said electrical signal represents the average gas present in the electrolytic fluid throughout the implanted predetermined length of said tube.

11. A method as in claim 1 including the step of measuring said electric signal on successive days and applying a predetermined and different correction factor to such signal for each day.

12. A method as in claim 11 where said correction factor is progressively reduced day-by-day.

13. A method as in claim 12 where said correction factor is a constant after a predetermined number of days.

14. A method as in claim 11 where on successive days the transient response to said gas is different and definable.

15. Apparatus for the direct tension measurement by a gas polarography technique by use of a tube in such tissue comprising:

a gas permeable tube of relatively small diameter suitable for implantation through said tissue leaving both ends exposed said tube being filled with an electrolytic fluid so that gas from the tissue may permeate through the tube into the fluid;

a gas electrode and a reference electrode inserted into said tube and into said electrolytic fluid at respective ends of the tube;

means for applying a polarographic potential between said gas and said reference electrodes;

means for measuring the resultant electrical signal from said gas electrode.

16. Apparatus as in claim 15 including means for calibrating said gas electrode.

17. Apparatus as in claim 15 in which said electrical signal from said gas electrode is measured by an ammeter circuit which is entirely portable and battery powered.

18. Apparatus as in claim 15 in which said polarographic potential is produced by a portable battery source.

19. Apparatus as in claim 18 in which said battery source for the polarographic potential includes a memory cell.

20. Apparatus as in claim 15 in which said tube is of a material substantially impermeable to protein from said tissue to thus protect the gas electrode from protein poisoning.

21. Apparatus as in claim 15 in which said gas electrode is a platinum wire encased in a rigid tubular shield.

22. Apparatus as in claim 15 in which said electrolytic fluid is 0.9 percent saline.

23. Apparatus as in claim 15 in which said reference electrode is a silver/silver chloride electrode.

24. Apparatus as in claim 15 where one end of said tube is coupled to one port of a three port valve, where all ports interconnect, one of said electrodes being inserted through a second port into said electrolytic fluid and the third port being connected to a hypodermic syringe serving as a source of said electrolytic fluid.

25. Apparatus for directly measuring tissue gas tension in tissue subcutaneously comprising:

(a) A catheter having an oxygen permeable membrane positionable in subcutaneous tissue for directly measuring tissue gas tension;

(b) an electrolyte in said catheter in chemical contact with the oxygen permeable membrane;

(c) an electrode sensitive to oxygen in the catheter in electrical contact with said electrolyte; and

(d) a reference electrode in the catheter in electrical contact with said electrolyte, so that when said catheter is positioned in subcutaneous tissue the oxygen in said tissue permeates said membrane, and reaches chemical equilibrium with the electrolyte and an electrical signal is developed between said oxygen sensitive electrode and said reference electrode corresponding to the tissue gas tension in the subcutaneous tissue.

26. Apparatus as in claim 25 further including means, connectable to said electrodes, for substantially instantaneously indicating the relative tissue gas tension in the subcutaneous tissue.

27. Apparatus as in claim 25 further including means, connectable to said oxygen electrode and said reference electrode, for applying a polarographic potential between said electrodes and for indicating the resultant electrical signal corresponding to the relative tissue gas tension in the subcutaneous tissue.