Reference electrode catheter

• US 4,432,366 A
• Filed: 11/27/1981
• Issued: 02/21/1984
• Est. Priority Date: 11/27/1981
• Status: Expired due to Term

• Current Assignee: Sentron VOF Oosteinde 8 9301 LJ Roden The Netherlands
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Margules, Gary S.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/325,402
• Time in Patent Office: 816 Days
• Field of Search: 128/635, 204/195 B, 204/195 P, 204/403, 204/414, 204/415, 204/435, 204/433
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence

Abstract

A reference electrode catheter for use for in vivo measurement of body fluids. The catheter includes a small diameter cylindrical tube having a reference electrode assembly disposed on the distal end thereof. The reference electrode assembly includes a hollow cylindrical housing and an electrode element positioned within the housing mounted on and supported by a retainer member. The electrode element is connected to an electrical conductor which extends out of the housing and through the passageway of the tubing to the proximal end of the tubing. An electrolytic material, such as gelled Ringer'"'"'s solution, is disposed within the housing, and a membrane formed of hydrogel is positioned across an aperture in the housing so as to form an ion diffusion barrier between the body fluids to be measured and the electrolytic material within the housing.

Claims

1. A reference electrode catheter for use in potentiometric electroanalysis in body fluids comprising:

an elongated cylindrical tubing having proximal and distal ends and having a passageway extending throughout the entire length thereof;

a hollow cylindrical housing member being mounted at the distal end of said tubing and having enclosed ends to thereby form a sealed chamber within said housing member, an aperture extending through a wall of said housing member and communicating with said chamber;

an electrode positioned within said chamber;

a conductive lead connected to said electrode and extending out of the housing member and through said passageway of said tubing to the proximal end of said tubing;

retainer means positioned within said housing member for supporting said electrode;

electrolytic material disposed within the chamber of the cylindrical housing member and in contact with said electrode; and

,

a biocompatible porous liquid junction comprised of a hydrogel being positioned across said aperture in said housing member so as to form an ion diffusion control barrier between body fluids and the electrolytic material within the chamber in said housing member for providing a stable liquid junction potential in body fluids to provide a substantially voltage stable reference electrode.

2. A catheter as defined in claim 1 wherein said hydrogel biocompatible porous liquid junction is formed of poly(hydroxethylmethacrylate).

3. A catheter as defined in claim 1 wherein said hydrogel biocompatible porous liquid junction is comprised of a selected one of the group consisting of:

poly(hydroxyethylmethacrylate), poly(glyceryl methacrylate), poly(hydroxypropyl methacrylate), poly(hydroxyethoxyethyl methacrylate poly(hydroxydiethoxyethyl methacrylate), poly(methoxyethyl methacrylate), poly(methoxyethoxyethyl methacrylate), poly(methoxydiethoxyethyl methacrylate), poly(2,3-dihydroxypropyl methacrylate).

4. A catheter as defined in claim 1 wherein said elongated cylindrical tubing has a second passageway extending throughout the entire length thereof, the second passageway being positioned such that the distal end of the passageway is disposed in proximity to an outer surface of the hydrogel biocompatible porous liquid junction so that fluid passing through said second passageway in a direction from the proximal end to the distal end of the elongated cylindrical tubing provides a flushing action across the outer surface of the hydrogel biocompatible porous liquid junction.

5. A catheter as defined in claim 4 wherein said electrolytic material is gelled Ringer'"'"'s solution.

6. A catheter as defined in claim 1 wherein said electrolytic material is gelled Ringer'"'"'s solution.

7. The catheter of claim 1 wherein said aperture is in a side wall of said housing member.

8. The catheter of claim 1 wherein said electrode is made, at least in part, of silver/silver chloride.

9. A reference electrode assembly for potentiometric electroanalysis in body fluids comprising:

a hollow cylindrical housing member having enclosed ends to thereby form a sealed chamber within said housing member, an aperture extending through a wall of said housing member and communicating with said chamber;

an electrode positioned within the chamber;

a conductive lead connected to the electrode and extending out of the housing member;

retainer means positioned within said housing member for supporting said electrode;

electrolytic material disposed within the chamber of the cylindrical housing member and in contact with said electrode; and

a biocompatible porous liquid junction comprised of a hydrogel being positioned across said aperture in said housing member so as to form an ion diffusion control barrier between body fluids to be measured and the electrolytic material within the chamber in said housing member for providing a stable liquid junction potential in body fluids to provide a substantially voltage stable reference electrode.

10. A reference electrode assembly as defined in claim 9 wherein said hydrogel biocompatible porous liquid junction is poly(hydroxyethylmethacrylate).

11. A reference electrode assembly as defined in claim 9 wherein said hydrogel biocompatible porous liquid junction is comprised of a selected one of the group consisting of:

poly(hydroxyethylmethacrylate), poly(glyceryl methacrylate), poly(hydroxypropyl methacrylate), poly(hydroxyethoxyethyl) methacrylate, poly(hydroxydiethoxyethyl methacrylate), poly(methoxyethyl methacrylate), poly(methoxyethoxyethyl methacrylate), poly(methoxydiethoxyethyl methacrylate), poly(2,3-dihydroxypropyl methacrylate).

12. A reference electrode assembly as defined in claim 9 wherein said electrolytic material is gelled Ringer'"'"'s solution.

13. A reference electrode assembly as defined in claim 9 wherein said biocompatible porous liquid junction is comprised of hydrogel formed by polymerizing a selected one from the group of monomers comprising:

hydroxyalkyl methacrylate, acrylamide derivatives, n-vinyl pyrrolidene, hydrophobic acrylics, acrylic acid derivatives, crotonic acid, sodium styrene sulfonate, aminoethyl methacrylate derivatives and vinyl pyridine.

14. The reference electrode assembly of claim 9 wherein said aperture is in a side wall of said housing member.

15. The reference electrode assembly of claim 9 wherein said electrode is made, at least in part, of silver/silver chloride.

16. A reference electrode assembly as defined in claim 9 combined with a catheter connected to said housing member and comprising a cylindrical tubing having proximal and distal ends and having a passageway extending throughout the entire length thereof and wherein said conductive lead extends through said passageway throughout the length of said lead to said housing member.

17. A reference electrode assembly and catheter combination as defined in claim 16 wherein said cylindrical tubing has a second passageway extending throughout the entire length thereof, the second passageway being positioned such that the distal end of the passageway is disposed in proximity to an outer surface of the hydrogel biocompatible porous liquid junction so that fluid passing through said second passageway in a direction from the proximal end to the distal end of the cylindrical tubing provides a flushing action across the outer surface of the hydrogel biocompatible porous liquid junction.

18. A reference electrode assembly and catheter combination as defined in claim 17 wherein said electrolytic material is gelled Ringer'"'"'s solution.