Self-guiding, multifunctional visceral catheter

• US 5,531,714 A
• Filed: 03/27/1995
• Issued: 07/02/1996
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/411,101
• Time in Patent Office: 463 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, 128/634
• US Class Current: 604/264
• 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 fiberoptic sensor systems 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 vena cava. A substantial difference between analyte concentration values as measured via the two fiberoptic sensor systems provides immediate confirmation that the catheter is properly positioned. In addition to being self-guiding, the catheter provides for direct sampling of venous blood; includes a fiberoptic system for continuously monitoring oxygen saturation in the hepatic or renal venous blood; and is capable of measuring absolute hepatic or renal blood flow. An integral operating unit incorporates necessary fiberoptic system components such as a light source and signal detector, as well as a microprocessor and program memory for implementing various functions of the catheter.

Claims

1. A visceral catheter, comprising:

a 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 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 lower than systemic values of said analyte outside said visceral venous system;

said sensor means comprising a fiberoptic sensor system; and

said detector means processes said signals from said fiberoptic sensor system and alerts a user to a substantial decrease in said values of said analyte when said sensor means is disposed within said predetermined venous system in said operable position of said catheter.

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

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

said portion of said catheter body which is positioned within said predetermined venous system in said operable position of said catheter comprises said angled distal end portion of said catheter body;

said fiberoptic sensor system comprises;

an optical fiber extending along said catheter body from said proximal end thereof to said angled distal end portion of said catheter body; and

a light source operatively cooperating with a proximal end portion of said optical fiber so as to transmit light to said optical fiber.

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

said predetermined visceral venous system comprises the hepatic venous system;

said predetermined analyte comprises galactose;

said fiberoptic sensor system further comprises an optode provided at a distal end of said optical fiber, said optode comprising biochemical sensor material provided within a semipermeable membrane; and

said biochemical sensor material generates fluorescent signals which vary according to detected values of galactose.

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

said biochemical sensor material comprises galactose oxidase and luminol.

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

said biochemical sensor material comprises galactose oxidase, pyrene butyric acid, and catalase.

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

said optical fiber forms part of a simple reflectance spectrophotometric system; and

said light source transmits light to said optical fiber at a predetermined wavelength which corresponds to absorption characteristics of said predetermined analyte.

7. A visceral catheter, comprising:

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

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

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

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

said 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;

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

each of said fiberoptic sensor means including an optical fiber having a light-receiving end portion; and

illuminating means for transmitting light to said light-receiving end portions of each of said optical fibers.

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

said catheter body comprises a main axial portion including 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;

said optical fiber of said first fiberoptic sensor means extends along said catheter body from said proximal end thereof to a part of said main axial portion of said catheter body; and

said optical fiber of said second fiberoptic sensor means extends along said catheter body from said proximal end thereof to said angled distal end portion of said catheter body.

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

said first fiberoptic sensor means further comprises an optode provided at an end of said optical fiber disposed at said part of said main axial portion;

said second fiberoptic sensor means further comprises an optode provided at a distal end of said optical fiber;

each of said optodes comprises biochemical sensor material provided within a semipermeable membrane;

said predetermined visceral venous system comprises the hepatic venous system;

said predetermined analyte comprises galactose; and

said biochemical sensor material is generates fluorescent signals which vary according to detected values of galactose.

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

said biochemical sensor material comprises galactose oxidase and luminol.

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

said biochemical sensor material comprises galactose oxidase, pyrene butyric acid, and catalase.

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

each said optical fiber forms part of a simple reflectance spectrophotometric system; and

said illuminating means transmits light to said optical fibers at a predetermined wavelength which corresponds to absorption characteristics of said predetermined analyte.

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

said catheter body is substantially hollow; and

each said optical fiber is embedded in an inner surface of said catheter body.

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

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

said oxygen saturation monitoring means comprises an optical fiber extending along said catheter substantially from said proximal end to said distal end of said catheter body.

15. A visceral catheter according to claim 14, wherein:

said oxygen saturation monitoring means comprises a simple reflectance spectrophotometric system.

16. A visceral catheter according to claim 14, wherein:

said oxygen saturation monitoring means further comprises an oxygen optode provided at a distal end of said optical fiber of said monitoring means.

17. A visceral catheter according to claim 7, further comprising:

means for measuring blood flow in said visceral venous system, said blood flow measuring means comprising said first and second fiberoptic sensor means;

an integral operating unit for operating said first and second fiberoptic sensor means and said blood flow measuring means, said integral operating unit comprising said detector means and said illumination means;

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

18. A multifunctional visceral catheter, comprising:

a catheter body;

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

said guiding means comprising first fiberoptic sensor means for detecting values of a predetermined analyte in a vessel disposed outside said visceral venous system and for outputting signals related thereto, and second fiberoptic sensor means for detecting values of said predetermined analyte within said visceral venous system;

said first fiberoptic sensor means being disposed on a first portion of said catheter body which, in said operable position of said catheter body, remains outside said visceral venous system, and said second fiberoptic sensor means being disposed on a second portion of said catheter body which, in said operable position of said catheter body, is positioned within said visceral venous system;

said catheter body comprising a main axial portion 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 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;

an integral operating unit, said integral operating unit comprising detector means, selectively connected to said first and second fiberoptic sensor means, for comparing said signals from said first and second fiberoptic sensor means and for alerting a user to a substantial difference between said signals;

third fiberoptic sensor means for monitoring the oxygen saturation of blood in said visceral venous system, said third fiberoptic sensor means being disposed substantially at a distal end of said catheter body;

means for measuring blood flow in said visceral venous system, said blood flow measuring means comprising said first and second fiberoptic sensor means; and

said integral operating unit further comprising;

illuminating means for transmitting light to said first, second, and third fiberoptic sensor means;

a microprocessor;

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

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

each of said first, second, and third fiberoptic sensor means comprises an optical fiber having an optode sensor provided at an analyte-detecting end of said optical fiber;

said optode sensor of said third fiberoptic sensor means comprises an oxygen optode.

20. A multifunctional visceral catheter according to claim 19, wherein:

said predetermined visceral venous system comprises the hepatic venous system;

said predetermined analyte comprises galactose;

each of said optode sensors of said first and second fiberoptic sensor means comprises biochemical sensor material provided within a semipermeable membrane; and

said biochemical sensor material generates fluorescent signals which vary according to detected values of galactose.