Method for transcutaneous measurement of a blood parameter and an electrochemical measuring electrode device for carrying out the method

• US 4,539,994 A
• Filed: 06/06/1983
• Issued: 09/10/1985
• Est. Priority Date: 10/13/1981
• Status: Expired due to Term

• Current Assignee: Radiometer A/S (Danaher Corporation)
• Original Assignee: Radiometer A/S (Danaher Corporation)
• Inventors: Poulsen, Jorgen, Baumbach, Per L.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/509,441
• Time in Patent Office: 827 Days
• Field of Search: 128/635, 204/403, 204/408, 204/415, 204/431, 204/433
• US Class Current: 600/358
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: G01K 1/16 Special arrangements for conducting heat from the object to the sensitive element
• CPC Class Codes: G01K 1/165 for application in zero heat flux sensors
• CPC Class Codes: G01K 1/20 Compensating for effects of temperature changes other than those to be measured, e.g. changes in ambient temperature

Abstract

In accordance with the principles for transcutaneous measurement of a blood parameter, such as the partial pressure of a blood gas, an electrochemical measuring electrode device (1) is applied to the skin surface (2) of a person. The electrode device has a body (10), e.g. a thick film substrate, which is thermostated to a predetermined temperature and, furthermore, includes a sensor (11) together with a membrane (14) confining an electrolyte solution within an electrolyte reservoir (15). Furthermore, the electrode device includes a jacket having an annular metallic body (16), a metallic body (4) and a thick film substrate (8), which is thermostated to the same temperature as the body (10) of the electrode device. When the body is brought into contact with the skin surface, an annular surface part of the jacket is also brought into contact with the skin surface so that a virtual heating jacket is established in the skin beneath the annular surface part so as to substantially direct all heat flow from the body to tissue directly beneath the skin surface. By measuring the power supplied for thermostating the body to the predetermined temperature, the local capillary blood flow in the tissue (2) beneath the skin is measured, and the blood parameter in question is measured by means of the sensor (11). In an alternative operational mode, the electrode device is adapted to measure deep body temperature by thermostating the jacket to a temperature so that the temperature registered by a temperature sensor of the body and the temperature registered by a temperature sensor of the jacket are identical to one another and, consequently, identical to the deep body temperature.

Claims

1. An electrochemical measuring electrode device for transcutaneous measurement of a blood parameter, said device comprising:

a body formed of a heat conductive material, said body including a surface part for application to a skin surface in heat conductive relationship therewith, sensor means for operatively responding to said blood parameter, and first thermostating means for thermostating said body to a predetermined temperature,

said device further comprising, a container-shaped jacket formed of a heat conductive material, said jacket including an annular surface part defining an opening in said jacket, said body being mounted within said jacket in spaced heat-insulating relationship therewith, said surface part of said body being substantially flush with said annular surface part so that said annular surface part is in heat conductive relationship with the skin surface when said surface part of said body is in heat conductive relationship with the skin surface, said jacket further including second thermostating means for thermostating said jacket to such a temperature that the heat transport or heat flux from said body is substantially unidirectional, whereby the spaced heat-insulating relationship between said body and said jacket enables said jacket to establish, in operation, a virtual heating jacket in the skin beneath said annular surface part so as to substantially direct all heat flow from said body to skin layers directly beneath said body.

2. The electrochemical measuring electrode device according to claim 1, wherein said body has an outer periphery, said jacket has an inner surface adjacent to the outer periphery of said body, and the spaced heat-insulating relationship between said body and said jacket is such that a substantially narrow space is defined between the outer periphery of said body and the adjacent inner surface of said jacket.

3. The electrochemical measuring electrode device according to claim 1, wherein said first and second thermostating means comprise means for heating said body and said jacket to the same temperature so as to obtain a zero heat flux between said body and said jacket.

4. The electrochemical measuring electrode device according to claim 1, wherein said body has a substantially circular cylindrical shape.

5. The electrochemical measuring electrode device according to claim 4, wherein said jacket includes a substantially annular part which is arranged coaxially relative to said body.

6. The electrochemical measuring electrode device according to claim 1, wherein said body is disc-shaped.

7. The electrochemical measuring electrode device according to claim 1, wherein said first thermostating means comprises an NTC-resistor and a heating resistor.

8. The electrochemical measuring electrode device according to claim 1 and further including a first thick film substrate, said first thermostating means being arranged on said first thick film substrate.

9. The electrochemical measuring electrode device according to claim 8, wherein said first thermostating means comprises thick film components disposed on said first thick film substrate.

10. The electrochemical measuring electrode device according to claim 8, wherein said body is formed of said first thick film substrate.

11. The electrochemical measuring electrode device according to claim 8, wherein said first thick film substrate has a plane or plane-convex shape.

12. The electrochemical measuring electrode device according to claim 8, wherein said first thick film substrate has a thickness of about 0.2-1.5 mm, and preferably about 0.3-0.8 mm.

13. The electrochemical measuring electrode device according to claim 8, wherein said first thick film substrate has a diameter of about 5-12 mm.

14. The electrochemical measuring electrode device according to claim 8, wherein said first thick film substrate is made of alumina or beryllia.

15. The electrochemical measuring electrode device according to claim 1, wherein said second thermostating means comprises an NTC-resistor and a heating resistor.

16. The electrochemical measuring electrode device according to claim 8, wherein said jacket further includes a second thick film substrate and said second thermostating means is arranged on said second thick film substrate in heat-conductive connection with said jacket.

17. The electrochemical measuring electrode device according to claim 16, wherein said second thermostating means comprises thick film components disposed on said second thick film substrate.

18. The electrochemical measuring electrode device according to claim 16, wherein said second thick film substrate comprises a circular substrate.

19. The electrochemical measuring electrode device according to claim 16, wherein said second thick film substrate has a plane or plane-convex shape.

20. The electrochemical measuring electrode device according to claim 16, wherein said second thick film substrate is made of alumina or beryllia.

21. The electrochemical measuring electrode device according to claim 1, wherein the thermal resistance between said jacket and said body is at least one order of magnitude (power of 10) greater than the thermal resistance between the body and the capillary bed beneath the skin surface.

22. The electrochemical measuring electrode device according to claim 1, wherein said sensor means comprises measuring means for measuring the partial pressure of a blood gas.

23. The electrochemical measuring electrode device according to claim 22, wherein said measuring means comprises a cathode of a noble metal capable of electrochemical reduction of oxygen, and an anode cooperating with said cathode and preferably being a silver anode, for measuring the partial pressure of oxygen in blood.

24. The electrochemical measuring electrode device according to claim 1, further comprising a membrane and an electrolyte solution, said membrane being adjacent to said surface part of said body so as to define a space wherein said electrolyte solution is confined.

25. A method of transcutaneous measurement of a blood parameter, comprising:

applying, to a skin surface of a person, an electrochemical measuring device comprising, in combination;

a body formed of a heat conductive material, said body including a surface part for application to the skin surface in heat-conductive relationship therewith, sensor means for operatively responding to said blood parameter, and first thermostating means for thermostating said body to a predetermined temperature, and a container-shaped jacket formed of a heat-conductive material, said jacket including an annular surface part defining an opening in said jacket, said body being mounted within said jacket in spaced heat-insulating relationship therewith, said surface part of said body being substantially flush with said annular surface part so that said annular surface part is in heat conductive relationship with the skin surface when said surface part of said body is in heat conductive relationship with the skin surface, and said jacket further including second thermostating means for thermostating said jacket to a particular temperature,

thermostating said body to a predetermined temperature with said first thermostating means,

thermostating said jacket to such a temperature with said second thermostating means that the heat transport or heat flux from said body is substantially unidirectional so that said jacket establishes a virtual heating jacket in the skin surrounding the periphery of said body to substantially direct all heat from said body to skin layers directly beneath said body,

measuring the power supplied for thermostating said body to said predetermined temperature to enable estimation of the blood flow in the skin with which the body is in heat conductive relationship, and

measuring the blood parameter by means of said sensor means.

26. The method according to claim 25, wherein said body and said jacket are thermostated to the same temperature.

27. The method according to claim 25, wherein said blood parameter is the partial pressure of a blood gas.

28. The method according to claim 25, wherein, in an alternative operational mode, said first thermostating means includes temperature sensing means for measuring the temperature of said first thermostating means, said second thermostating means includes temperature sensing means for measuring the temperature of said second thermostating means, and said jacket is thermostated to such a temperature that the temperature registered by the temperature sensing means of said first thermostating means and the temperature registered by the temperature sensing means of said second thermostating means are identical to one another and, consequently, identical to the deep body temperature.