Sensor assembly suitable for blood gas analysis and the like and the method of use

• US 4,615,340 A
• Filed: 01/28/1986
• Issued: 10/07/1986
• Est. Priority Date: 02/27/1985
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cronenberg, Richard A., Shapiro, Stephen I.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Smith, Ruth S.
• Application Number:
  US06/822,963
• Time in Patent Office: 252 Days
• Field of Search: 128/632, 128/635, 128/765, 204/415
• US Class Current: 600/360
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3

Abstract

A sensor assembly for electrochemical analysis of a substance comprises a housing and electrodes for sensing selective gases and ions within the housing. A sampler is associated with the housing for introducing the substance to be analyzed into the housing and for allowing the selective gas and ion content thereof to be sensed without physical contact with the gas and ion sensing electrodes. A method of detecting gases and ions in a substance comprises withdrawing a quantity of a substance from a source and directly contacting the substance with a gas and ion permeable medium as it is withdrawn from the source. Gases and ions are caused to permeate through the medium whereupon the gases and ions are detected by a sensing mechanism.

Claims

1. A hand-holdable sensor assembly suitable for use in a device for blood gas analysis and the like at the bedside of a patient comprising:

a portable housing sized to be held by the hand of a user having an open end;

electrode means, including electrodes for sensing oxygen, carbon dioxide and hydrogen ions located inside said housing and spaced from said open end by a recess;

a gas-permeable, ion-impermeable membrane positioned within said recess and covering said oxygen and carbon dioxide electrodes;

means for connecting said electrodes into an electrical circuit which includes means for measuring and displaying values of pO₂, pCO₂ and pH sensed by the respective electrodes; and

a blood sampler having a cavity covered by a gas and ion-permeable membrane, a port communicating with said cavity for the entry of blood therein, said port adapted for connection to a needle for penetrating a blood vessel of the patient, and a vent port communicating with said cavity, said vent port including means for allowing air to pass out of said cavity, but not blood, said sampler being removably positioned in said recess so that said membranes are in substantially face-to-face engagement and said ion electrode is in contact with said gas and ion-permeable membrane of said sampler.

2. The assembly of claim 1 wherein said oxygen and carbon dioxide electrodes are measuring anodes and said assembly further includes a common electrode serving as a cathode associated with said anodes.

3. The assembly of claim 2 wherein said oxygen, carbon dioxide and common electrodes are contained within an inner body positioned inside said housing and are immersed in an electrolyte medium and covered by said gas-permeable, ion-impermeable membrane.

4. The assembly of claim 1 wherein said gas-permeable, ion-impermeable membrane is removable from said assembly.

5. The assembly of claim 1 which further includes another electrode serving as a hydrogen ion reference electrode during the measurement of pH values.

6. The assembly of claim 1 which further includes a heater located near said recess for heating the housing area around said electrodes and the recess into which said blood sampler is positioned.

7. The assembly of claim 6 which further includes a sensing element for measuring the temperature to which said housing area is heated.

8. The assembly of claim 1 wherein said gas-permeable, ion-impermeable membrane is made of polytetrafluorethylene and said gas and ion permeable membrane is made of cellulosic material.

9. The assembly of claim 1 wherein said means for connecting includes an electrical line having a sufficient number of electrical conduits to carry a plurality of signals from said housing to the electrical circuit for measuring and displaying said values.

10. The assembly of claim 1 wherein the entry port of said sampler includes a tapered extension therearound onto which a hub of a needle is adapted to be connected.

11. The assembly of claim 1 wherein said vent port means of said sampler includes an air-permeable, liquid-impermeable membrane thereacross.

12. A hand-holdable sensor assembly for use in a device for blood gas analysis at the bedside of a patient comprising:

a wand-like, portable housing sized to be held by the hand of a user and having an open end;

an inner body positioned inside said housing and spaced from said open end by a recess, said body containing oxygen and carbon dioxide measuring electrodes and a common reference electrode associated with said measuring electrodes, all of said electrodes immersed in an electrolyte medium, said inner body being covered by a gas-permeable, ion-impermeable membrane facing said recess;

pH and pH reference electrodes in said housing located near said recess;

electrical lead wires attached to said electrodes for connecting same into an electrical circuit which includes means for measuring and displaying values of oxygen, carbon dioxide and pH sensed by the respective electrodes; and

a blood sampler having a cavity covered by a gas and ion permeable membrane, a port communicating with said cavity for the entry of blood therein, said port adapted for connection to a needle for penetrating a blood vessel of the patient, a vent port communicating with said cavity including an air-permeable, liquid-impermeable membrane thereacross adapted to allow air to pass out of said cavity but not blood, said sampler being removably positioned in said recess so that said membranes are in face-to-face engagement and said pH electrode is in contact with said gas and ion permeable membrane of said sampler.

13. A hand-holdable sensor for use in a device for blood gas analysis and the like at the bedside of a patient comprising:

a portable housing sized to be held by the hand of a user having an open end;

electrode means, includng electrodes, for sensing oxygen, carbon dioxide and hydrogen ions located inside said housing and spaced from said open end by a recess;

a gas-permeable, ion-permeable membrane positioned within said recess and covering only said oxygen and carbon dioxide electrodes; and

means for connecting said electrodes into an electrical circuit to measure values of pO₂, pCO₂ and pH sensed by the respective electrodes.

14. A method of measuring the partial pressures of oxygen and carbon dioxide and the pH level of arterial blood of a patient at bedside comprising:

withdrawing blood from an artery of a patient;

directing said blood as it is withdrawn into in vitro contact with a gas and ion-permeable membrane located at the bedside of a patient;

causing oxygen, carbon dioxide and hydrogen ions to permeate through said membrane and be sensed by measuring electrodes located at the bedside of the patient; and

providing information at bedside relating to measured values of the partial pressures of arterial oxygen and carbon dioxide and pH.

15. The method of claim 14 wherein said withdrawing step includes filling a blood sampler with a quantity of arterial blood, said sampler including said gas and ion-permeable membrane.

16. The method of claim 15 wherein said directing step includes placing said sampler so that said membrane is adjacent said measuring electrodes.

17. The method of claim 16 which further includes removing said sampler from its position adjacent said electrodes after said information is provided.

18. The method of claim 14 wherein said withdrawing step includes inserting a needle into an artery of the patient.

19. The method of claim 18 wherein oxygen, carbon dioxide and hydrogen ions are sensed by said measuring electrodes while said needle is still inserted in the patient.

20. The method of claim 14 wherein said providing step includes displaying the values of pO₂, pCO₃ and pH.

21. The method of claim 20 wherein said values are displayed digitally.

22. The method of claim 14 wherein said directing step includes holding a housing containing said electrodes in the hand of the user and connecting said housing into fluid communication with an artery of the patient so that arterial blood flows toward said housing.

23. A method of detecting gases and ions in blood comprising:

withdrawing blood from a living source;

directly contacting said blood with a gas and ion-permeable medium as it is being withdrawn;

causing gases and ions to permeate through said medium; and

detecting said gases and ions by sensing means.

24. The method of claim 23 wherein said detecting step includes providing information relating to measured values of the gases and ions detected.

25. The method of claim 23 wherein said detecting step includes detecting only pre-selected gases and ions in the blood.

26. A method of measuring the partial pressures of oxygen and carbon dioxide and the pH level of arterial blood of a patient at bedside comprising:

placing a blood sampler having a gas and ion-permeable membrane into close proximity to measuring electrodes sensitive to oxygen, carbon dioxide and hydrogen ions;

inserting a needle into an artery of a patient;

withdrawing blood from said artery directly into said sampler at the bedside of the patient;

causing oxygen, carbon dioxide and hydrogen ions to permeate through said membrane and be sensed by said electrodes;

displaying the sensed values of pO₂, pCO₂ and pH related to said arterial blood; and

removing said sampler from its position adjacent said electrodes after the values are sensed.

27. A method of detecting gases and ions in a substance comprising:

withdrawing a quantity of a substance from a source;

directly contacting said substance with a gas and ion-permeable medium as it is withdrawn from the source;

causing gases and ions to permeate through said medium; and

detecting said gases and ions by sensing means.