Self-guiding, multifunctional visceral catheter

• US 5,520,178 A
• Filed: 11/01/1994
• Issued: 05/28/1996
• Est. Priority Date: 11/01/1994
• Status: Expired due to Fees

• Current Assignee: Mary Dahn
• Original Assignee: Lange M. Patricia
• Inventors: Dahn, Michael S., Lange, M. Patricia
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/332,715
• Time in Patent Office: 574 Days
• Field of Search: 604/264, 604/270, 604/280-282, 128/637, 128/639, 128/642, 128/654, 128/656, 128/657, 128/658, 128/691, 128/692, 128/772
• US Class Current: 600/368
• CPC Class Codes: A61B 5/0275 using tracers, e.g. dye dilution
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0116 self-propelled, e.g. autonomous robots A61M25/0122 takes precedence

Abstract

A multifunctional visceral catheter having a self-guiding system in the form of a pair of electrochemical sensors which are sensitive to a predetermined analyte, the analyte being one which is removed from the vascular circuit of interest to a high degree, such as galactose in the hepatic venous system or creatinine in the renal venous system. One of the sensors is disposed on the catheter so as to be positioned within the venous system of interest, while the other sensor remains outside the venous system in the inferior vena cava. A substantial difference between analyte concentration values as measured via the two sensors provides immediate confirmation that the catheter is properly positioned, eliminating the need for fluoroscopy or other x-ray techniques. In addition to being self-guiding, the catheter provides for direct sampling of venous blood; is capable of continuously monitoring oxygen saturation in the hepatic or renal venous blood; and is capable of measuring absolute hepatic or renal blood flow using a tracer clearance technique.

Claims

1. A visceral catheter, comprising:

a main catheter body having a proximal end and a distal end;

means for guiding said catheter to an operable position in which a portion of said main body is disposed within a predetermined visceral venous system, said guiding means comprising;

first sensor means for detecting values of a predetermined analyte in a vessel disposed outside said visceral venous system in said operable position of said catheter and for outputting signals related thereto, said first sensor means being disposed on a first portion of said main catheter body which remains in said vessel outside said visceral venous system in said operable position of said catheter;

second sensor means for detecting values of said predetermined analyte within said visceral venous system in said operable position of said catheter and for outputting signals related thereto, said second sensor means being disposed on a second portion of said main catheter body which is positioned within said visceral venous system in said operable position of said catheter;

said main catheter body comprising a main axial portion extending from said proximal end and an angled distal end portion extending from said main axial portion, said second portion of said catheter body being disposed on said angled distal end portion of said catheter body;

said predetermined analyte having a specific relationship to an organ associated with said predetermined visceral venous system such that values of said analyte within said visceral venous system are substantially different from systemic values of said analyte outside said visceral venous system; and

said first and second sensor means being selectively connected to detector means for comparing said signals from said first and second sensor means and for alerting a user to a substantial difference between said signals.

2. A visceral catheter according to claim 1, wherein:

said angled distal end portion extends from said main axial portion at an acute angle; and

said first portion of said catheter body is disposed on said main axial portion of said catheter body.

3. A visceral catheter according to claim 2, wherein:

said angled distal end portion extends from said main axial portion at an angle of substantially 65°

.

4. A visceral catheter according to claim 2, wherein:

said first and second sensor means each comprises an electrochemical sensing system including an electrode with a hydratable membrane containing a reagent which detects values of said predetermined analyte.

5. A visceral catheter according to claim 4, wherein:

said predetermined visceral venous system comprises the hepatic venous system;

said predetermined analyte comprises galactose; and

said hydratable membrane of said first and second sensor means contains galactose oxidase.

6. A visceral catheter according to claim 4, wherein:

said predetermined visceral venous system comprises the renal venous system;

said predetermined analyte comprises creatinine; and

said hydratable membrane of said first and second sensor means contains creatinine amidohydrolase.

7. A visceral catheter according to claim 4, wherein:

said main catheter body is substantially hollow; and

said first and second sensor means are selectively connected to said detector means via electrical conductors which extend along an inner surface of said catheter body.

8. A visceral catheter according to claim 4, wherein:

said catheter further comprises means for measuring blood flow in said visceral venous system, said blood flow measuring means comprising said first and second sensor means, and said detector means;

said detector means comprising a microprocessor and program memory, wherein;

said program memory is programmed for computing concentration values of said predetermined analyte, and stores at least one equation for calculating blood flow values based on said concentration values; and

said microprocessor receives said signals from said first and second sensor means and utilizes said program memory to calculate concentration values of said predetermined analyte based on said signals from said first and second sensor means, and to calculate said blood flow values utilizing said at least one stored equation and said concentration values.

9. A visceral catheter according to claim 1, wherein:

said catheter further comprises means for monitoring the oxygen saturation of blood in said visceral venous system;

said main catheter body is substantially hollow; and

said oxygen saturation monitoring means comprises a fiber optic cable extending along an inner surface of said catheter, substantially from said proximal end to said distal end of said catheter body.

10. A catheter, comprising:

a main catheter body;

first sensor means for detecting values of a predetermined analyte in a vessel disposed outside a predetermined venous system in an operable position of said catheter and for outputting signals related thereto, said first sensor means being disposed on a first portion of said main catheter body which remains in said vessel outside said predetermined venous system in said operable position of said catheter;

second sensor means for detecting values of said predetermined analyte within said predetermined venous system in said operable position of said catheter and for outputting signals related thereto, said second sensor means being disposed on a second portion of said main catheter body which is positioned within said venous system in said operable position of said catheter;

said first and second sensor means being selectively connected to detector means for receiving and processing said signals from said first and second sensor means;

said detector means comprising a microprocessor and program memory, wherein;

said program memory is programmed for computing concentration values of said predetermined analyte; and

said microprocessor receives said signals from said first and second sensor means and utilizes said program memory to calculate concentration values of said predetermined analyte based on said signals from said first and second sensor means.

11. A catheter according to claim 10, wherein:

said program memory stores at least one equation for calculating blood flow values on the basis of said analyte concentration values; and

said microprocessor calculates said blood flow values utilizing said at least one stored equation and said calculated analyte concentration values.

12. A catheter according to claim 10, wherein:

said main catheter body comprises a main axial portion extending from said proximal end and an angled distal end portion extending from said main axial portion at an acute angle;

said first portion of said catheter body is disposed on said main axial portion of said catheter body; and

said second portion of said catheter body is disposed on said angled distal end portion of said catheter body.

13. A catheter according to claim 12, wherein:

said angled distal end portion extends from said main axial portion at an angle of substantially 65°

.

14. A catheter according to claim 12, wherein:

said first and second sensor means each comprises an electrochemical sensing system including an electrode with a hydratable membrane containing a reagent which detects values of said predetermined analyte.

15. A catheter according to claim 14, wherein:

said predetermined venous system comprises the hepatic venous system;

said predetermined analyte comprises galactose; and

said hydratable membrane of said first and second sensor means contains galactose oxidase.

16. A catheter according to claim 14, wherein:

said predetermined visceral venous system comprises the renal venous system.

17. A visceral catheter, comprising:

a main catheter body;

sensor means for detecting values of a predetermined analyte both within and outside a predetermined visceral venous system and for outputting signals related thereto, said sensor means being disposed on a portion of said main catheter body which, in an operable position of said catheter, is positioned within said predetermined visceral venous system;

said sensor means being selectively connected to detector means for receiving and processing signals from said sensor means;

said predetermined analyte comprising an analyte other than oxygen which has a specific relationship to an organ associated with said predetermined visceral venous system such that values of said analyte within said visceral venous system are substantially lower than systemic values of said analyte outside said visceral venous system; and

said detector means processes said signals from said sensor means and alerts a user, by virtue of a substantial decrease in said values of said analyte, when said sensor means is moved from a vessel outside said predetermined venous system to said operable position within said predetermined venous system.

18. A visceral catheter according to claim 17, wherein:

said main catheter body comprises a distal end and a proximal end, with a main axial portion extending from said proximal end and an angled distal end portion extending from said main axial portion at an acute angle; and

said sensor means is disposed on said angled distal end portion of said catheter body.

19. A visceral catheter according to claim 18, wherein:

said angled distal end portion extends from said main axial portion at an angle of substantially 65°

.

20. A visceral catheter according to claim 17, wherein:

said sensor means comprises an electrochemical sensing system including an electrode with a hydratable membrane containing a reagent which detects values of said predetermined analyte.