Intravascular oximetry catheter

• US 5,995,208 A
• Filed: 05/28/1998
• Issued: 11/30/1999
• Est. Priority Date: 05/28/1998
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Tsuchitani, Scott T., Vurek, Gerald G., Sarge, Jeffrey A., Ogi, Darrell H., Christianson, Harlow B., Sperinde, John M.
• Primary Examiner(s): Font, Frank G.
• Assistant Examiner(s): Ratliff, Reginald A.
• Application Number:
  US09/086,789
• Time in Patent Office: 551 Days
• Field of Search: 356/39, 356/41, 356/42
• US Class Current: 356/39
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence

Abstract

Apparatus and a method for monitoring a percentage of the oxygen saturation in the hemoglobin of blood flowing through a blood vessel. An optical sensor that detects the percentage oxygen saturation in blood is disposed proximate a proximal end of the catheter. A thermistor is disposed adjacent to the distal end of the catheter and it is employed to detect changes in blood temperature that indicate the position of the catheter'"'"'s distal end in the blood vessel. Indicia or marks visible at intervals on the outer surface of the catheter enable a medical practitioner to determine the length of the catheter that has been introduced into the blood vessel. A strain relief that is flexible and resists stretching extends along the length of the catheter. For flushing the distal end of the catheter, a fluid supply may be connected to a lumen running through the catheter to provide the flushing fluid. A removable guide wire is inserted in the lumen when positioning the distal end of the catheter at a location in the blood vessel and provides enhanced rigidity for this purpose. The catheter may be coated with an anticoagulant such as heparin, to prevent blood from coagulating on the exterior surface of the catheter.

Claims

1. Apparatus for monitoring a percentage of oxygen saturation in blood flowing through a blood vessel, comprising:

(a) a flexible catheter having an elongated cylindrical shape and a diameter sufficiently small to enable the catheter to be advanced into the blood vessel as the blood is flowing through the blood vessel;

(b) a pair of optical fibers disposed within the catheter and extending generally along the length of the catheter, from a point adjacent to a distal end of the catheter, one of said optical fibers being adapted for coupling to a transmitter and being used for conveying light from the transmitter, another of said optical fibers being adapted for coupling to a receiver and conveying reflected light to the receiver; and

(c) an oxygen sensor for indicating the percentage of oxygen saturation in the blood flowing through the blood vessel, the oxygen sensor including the transmitter and the receiver and being coupled to the proximal end of the catheter, the optical fibers being generally centered about a central longitudinal axis of the catheter, to maximize a distance between each distal end of each optical fiber and a periphery of the catheter, so that reflection of light emitted from a distal end of said one optical fiber from a wall of the blood vessel, which would cause an error in the percentage of oxygen saturation determined by the oxygen sensor, is substantially reduced.

2. The apparatus of claim 1, further comprising a thermistor disposed adjacent to the distal end of the catheter, said thermistor being adapted to sense a temperature of the blood flowing past the catheter.

3. The apparatus of claim 2, further comprising leads disposed within the catheter and coupled to the thermistor, said leads extending proximally from the thermistor through the catheter and having proximal ends adapted to couple to a temperature indicator that displays a temperature of the blood.

4. The apparatus of claim 3, wherein the temperature of the blood is employed to determine a relative position of the catheter within the blood vessel.

5. The apparatus of claim 1, wherein the transmitter is coupled to a proximal end of said one optical fiber and adapted for transmitting light that is emitted out of the distal end of said one optical fiber into the blood flowing past the distal end of the catheter, and the receiver is coupled to a proximal end of the other optical fiber and adapted for receiving reflected light from blood flowing past a distal end of said other optical fiber disposed at the distal end of the catheter, an intensity of said reflected light being indicative of the percentage of oxygen saturation in the blood.

6. The apparatus of claim 5, wherein the receiver receives light that is reflected by hemoglobin in a red blood cell.

7. The apparatus of claim 5, wherein the oxygen sensor further comprises a meter that displays the percentage of oxygen saturation in the blood.

8. The apparatus of claim 1, wherein the oxygen sensor has an alarm that indicates a relationship between the percentage of oxygen saturation and a predetermined value.

9. The apparatus of claim 1, wherein the catheter is coated with an anti-clotting agent.

10. The apparatus of claim 1, further comprising a strain relief member extending along the length of the catheter, the strain relief member being flexible and resistant to longitudinal stretching.

11. The apparatus of claim 10, wherein the strain relief member comprises a polymer thread.

12. The apparatus of claim 1, wherein the catheter includes a lumen extending generally along the length of the catheter that is adapted to receive a guide wire, the guide wire being inserted into the lumen to make the catheter less flexible and thereby facilitate positioning the distal end of the catheter at a predetermined position in the blood vessel, said guide wire being retracted from the lumen when the catheter is at the predetermined position.

13. The apparatus of claim 12, wherein the lumen is adapted to enable the guide wire to be reinsertable into the lumen to enable the user to reposition the distal end of the catheter in the blood vessel.

14. The apparatus of claim 1, wherein the lumen is adapted to couple to a fluid supply, the fluid supply being coupled to the lumen to enable the catheter to be flushed with a fluid to inhibit the coagulation of blood at the distal end of the catheter.

15. The apparatus of claim 5, wherein each edge of the distal end of each optical fiber is disposed at least 0.020 inches from a periphery of the distal end of the catheter.

16. The apparatus of claim 5, wherein a center-to-center distance between the distal ends of the pair of optical fibers is less than or equal to 0.0105 inches.

17. The apparatus of claim 1, wherein the blood vessel comprises one of an artery and a vein.

18. The apparatus of claim 1, further comprising a plurality of indicia visible on an outer surface of the catheter, positioned at intervals along the length of the catheter.

19. The apparatus of claim 18, wherein the plurality of indicia are provided to indicate a length of the catheter that has been inserted into the blood vessel.

20. The apparatus of claim 1, wherein the distal end of the catheter has a rounded edge disposed along the periphery of said distal end of the catheter.

21. A catheter for monitoring a percentage of oxygen saturation in blood flowing through a blood vessel, comprising:

(a) a lumen disposed within the catheter and extending along a length of the catheter;

(b) a pair of optical fibers extending through the lumen to a distal end of the catheter;

(c) a proximal end of one of the pair of optical fibers being adapted to couple to an optical transmitter disposed at a proximal end of the catheter to convey light emitted by the optical transmitter to a distal end of said one of the pair of optical fibers, for emission therefrom into the blood; and

(d) a proximal end of the other of the pair of optical fibers being adapted to couple to an optical receiver disposed at a proximal end of the catheter to convey light reflected from hemoglobin in red blood cells in the blood, distal ends of the pair of optical fibers being disposed substantially at a center of the distal end of the catheter to maximize a distance between a periphery of the catheter and the distal ends of the pair of optical fibers, and thereby to reduce the light emitted from the distal end of said one of the pair of optical fibers that is reflected from a wall of the blood vessel so that the light reflection does not cause a substantial error in an accuracy with which the percentage of oxygen saturation in the blood flowing through the blood vessel is monitored.

22. A method for monitoring the percentage of oxygen saturation in blood flowing through a blood vessel, comprising the steps of:

(a) opening an incision in a body of a patient, the incision providing an access into the blood vessel;

(b) providing a catheter that includes an optical fiber sensing system, said optical fiber sensing system including a transmitting optical fiber and a receiving optical fiber, a distal end of the transmitting optical fiber and a distal end of the receiving optical fiber being disposed substantially at a center of a distal end of the catheter, to maximize a distance between each distal end of each optical fiber and a periphery of the catheter, so that reflection of light emitted from a distal end of said one optical fiber from a wall of the blood vessel, which would cause an error in the percentage of oxygen saturation determined by the oxygen sensor, is substantially reduced;

(c) inserting the catheter into the blood vessel through the incision;

(d) positioning the distal end of the catheter at a position in the blood vessel, away from a wall of the blood vessel; and

(e) monitoring a percentage of the oxygen saturation in the blood flowing through the blood vessel with the optical fiber oxygen sensing system.

23. The method of claim 22, further comprising the step of inserting an introducer device into the incision, the intrusion device providing a more defined access into the blood vessel for insertion of the catheter.

24. The method of claim 22, further comprising the step of flushing the catheter with a fluid flowing through the catheter and out the distal end of the catheter into the blood vessel, so that the clotting of blood on the optical fiber oxygen sensing system is inhibited by the fluid.

25. The method of claim 22, wherein the step of inserting the catheter into the blood vessel through the incision further comprises the step of inserting a guide wire into a lumen disposed within the catheter and extending along a length of the catheter, the guide wire reducing the flexibility of the catheter to facilitate guiding the catheter through the blood vessel.

26. The method of claim 22, wherein the step of positioning the distal end of the catheter further comprising the steps of:

(a) advancing the catheter into the blood vessel until resistance is sensed; and

then

(b) moving the catheter back a predetermined distance away in the blood vessel.

27. The method of claim 26, wherein the predetermined distance is at least one centimeter.

28. The method of claim 22, wherein the step of positioning the distal end of the catheter comprises the step of determining a change in a temperature of the blood flowing past the distal end of the catheter, the change indicating the position of the distal end of the catheter in the blood vessel relative to a branch blood vessel.

29. The method of claim 22, wherein the step of positioning the distal end of the catheter comprises the step of monitoring a plurality of indicia disposed at periodic intervals along a length of the catheter to determine a length of the catheter disposed in the blood vessel.

30. The method of claim 22, further comprising the step of measuring the pressure of the blood flowing in the blood vessel through a lumen that is disposed in the catheter.

31. The method of claim 22, further comprising the step of sampling blood flowing in the blood vessel through a lumen that is disposed in the catheter.