Method and apparatus for monitoring blood chemistry

• US 5,758,643 A
• Filed: 07/29/1996
• Issued: 06/02/1998
• Est. Priority Date: 07/29/1996
• Status: Expired due to Term

• Current Assignee: Segars California Partners, LP
• Original Assignee: VIA Medical Corporation (Medtronic Plc)
• Inventors: Curry, Kenneth, Retana, Luis, Wong, David K., Gharib, James E.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/688,153
• Time in Patent Office: 673 Days
• Field of Search: 128/632, 128/635, 128/760, 604/4, 204/403, 204/409, 204/411
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An improved system is disclosed for monitoring a patient'"'"'s blood chemistry, wherein the system intermittently draws blood samples from the patient into a special sensor assembly having a plurality of analytical sensors, each sensitive to a particular parameter of the blood. After signals produced by these various sensors have been read, the system reinfuses the blood samples back into the patient. Withdrawal of the successive samples to a desired, optimal position within the sensor assembly is achieved by monitoring signals produced by one or more of the analytical sensors, themselves. This allows a catheter that connects the sensor assembly to the patient to have a variable length and internal volume and obviates the need for a separate, dedicated sensor for detecting the arrival of the blood sample at the desired position.

Claims

1. A method for monitoring a predetermined parameter of a patient'"'"'s blood while infusing an infusion fluid through a sensor assembly and catheter into the patient, the method comprising:

operating an infusion pump in a forward direction, to infuse the infusion fluid through the sensor assembly and catheter into the patient;

interrupting infusion of the infusion fluid into the patient by operating the infusion pump in a reverse direction, to draw a blood sample from the patient through the catheter and into the sensor assembly;

monitoring a signal produced by a first sensor of the sensor assembly and detecting a change in the signal indicative of the arrival of the blood sample at the first sensor;

ceasing operation of the infusion pump in the reverse direction in response to detecting the arrival of the blood sample at the first sensor; and

monitoring the first sensor signal while the blood sample is in sensing contact with the first sensor, to produce a measurement of a predetermined parameter of the patient'"'"'s blood.

2. A method as defined in claim 1, and further comprising again operating the infusion pump in the forward direction, to flush the blood sample from sensing contact with the first sensor back through the catheter and into the patient.

3. A method as defined in claim 2, and further comprising intermittently repeating the steps of operating, interrupting, monitoring, ceasing, monitoring, and again operating.

4. A method as defined in claim 1, wherein the first sensor, which produces the signal used in the steps of monitoring, is selected from the group consisting of a carbon dioxide sensor, an oxygen sensor, a potassium sensor, an hematocrit sensor, a calcium sensor, and a sodium sensor.

5. A method as defined in claim 4, wherein:

the sensor assembly includes a carbon dioxide sensor and a calcium sensor; and

the step of ceasing operation of the infusion pump in the reverse direction includes ceasing operation of the infusion pump in the reverse direction in response to a predetermined combination of a first signal generated by the carbon dioxide sensor and a second signal generated by the calcium sensor.

6. A method as defined in claim 1, wherein the first sensor, which produces the signal used in the steps of monitoring, is selected from the group consisting of an hematocrit sensor, a temperature sensor, and a pH sensor.

7. A method as defined in claim 1, and further comprising actuating an alarm in response to a predetermined signal from the first sensor.

8. A method as defined in claim 1, and further comprising actuating an alarm in response to the absence of a predetermined signal from the first sensor within a predetermined time period following initiation of the step of interrupting infusion of the infusion fluid.

9. A method as defined in claim 1, wherein ceasing operation of the infusion pump in the reverse direction occurs at a prescribed time after detecting the arrival of the blood sample at the first sensor.

10. A method as defined in claim 1, wherein ceasing operation of the infusion pump in the reverse direction occurs after a prescribed additional volume of blood has been drawn from the patient following the detecting of the arrival of the blood sample at the first sensor.

11. A method as defined in claim 1, wherein:

the sensor assembly includes a plurality of sensors in addition to the first sensor, each of the additional sensors producing a signal indicative of a different predetermined parameter of the adjacent fluid; and

the method further comprises monitoring the signals produced by the plurality of sensors of the sensor assembly, while the blood sample is in sensing contact with the sensors, to produce measurements of a plurality of different predetermined parameters of the patient'"'"'s blood.

12. A method for monitoring a predetermined parameter of a patient'"'"'s blood while infusing an infusion fluid through a sensor assembly and catheter into the patient, the method comprising:

operating an infusion pump in a forward direction, to infuse the infusion fluid through the sensor assembly and catheter into the patient;

interrupting infusion of the infusion fluid into the patient by operating the infusion pump in a reverse direction, to draw a blood sample from the patient through the catheter and into the sensor assembly;

monitoring signals produced by first and second sensors of the sensor assembly and detecting changes in the signals indicative of the arrival of the blood sample at the first and second sensors;

ceasing operation of the infusion pump in the reverse direction in a prescribed manner after detecting the arrival of the blood sample at the first and second sensors and

monitoring the signals produced by the first and second sensors of the sensor assembly, while the blood sample is in sensing contact with such sensors, to produce measurements of first and second predetermined parameters of the patient'"'"'s blood.

13. A method as defined in claim 12, and further comprising again operating the infusion pump in the forward direction, to flush the blood sample from sensing contact with the first and second sensors back into the patient.

14. A method as defined in claim 13, and further comprising intermittently repeating the steps of operating, interrupting, monitoring, ceasing, monitoring, and again operating.

15. A method as defined in claim 12, wherein the first sensor, which produces a signal used in the first step of monitoring, is selected from the group consisting of a carbon dioxide sensor, an oxygen sensor, a potassium sensor, a calcium sensor, and a sodium sensor.

16. A method as defined in claim 15, wherein:

the first sensor of the sensor assembly is a carbon dioxide sensor;

the second sensor of the blood chemistry sensor assembly is a calcium sensor; and

the step of ceasing operation of the infusion pump in the reverse direction includes ceasing operation of the infusion pump in the reverse direction in response to a predetermined combination of a first signal generated by the carbon dioxide sensor and a second signal generated by the calcium sensor.

17. A method as defined in claim 12, wherein the first sensor, which produces a signal used in the first step of monitoring, is selected from the group consisting of an hematocrit sensor, a temperature sensor, and a pH sensor.

18. A method as defined in claim 12, and further comprising actuating an alarm in response to a predetermined signal from the first sensor.

19. A method as defined in claim 12, and further comprising actuating an alarm in response to the absence of a predetermined signal from the first sensor within a predetermined time period following the step of interrupting infusion of the infusion fluid.

20. A method as defined in claim 12, wherein ceasing operation of the infusion pump in the reverse direction occurs after a prescribed additional volume of blood has been drawn from the patient following the detecting of the arrival of the blood sample at the first sensor.

21. A method as defined in claim 12, wherein:

the sensor assembly includes a plurality of sensors, in addition to the first and second sensors, each additional sensor producing a signal indicative of a different predetermined parameter of the adjacent fluid; and

the method further comprises monitoring the signals produced by the plurality of additional sensors of the sensor assembly, while the blood sample is in sensing contact with such additional sensors, to produce measurements of a plurality of different predetermined parameters of the patient'"'"'s blood.

22. Apparatus for monitoring a predetermined parameter of a patient'"'"'s blood while infusing an infusion fluid into the patient, comprising:

an infusion line and a catheter configured for insertion into a blood vessel of the patient;

a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter;

a blood chemistry sensor assembly mounted in fluid communication with the infusion line and including a first sensor that provides a signal indicative of a predetermined parameter of any fluid present in the infusion line; and

a controller that operates the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that intermittently interrupts its operating of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a blood sample from the patient through the catheter and infusion line into sensing contact with the first sensor of the blood chemistry sensor assembly;

wherein the controller further is configured to monitor the signal provided by the first sensor of the blood chemistry sensor assembly and to detect a change in the signal indicative of the arrival of the blood sample at the first sensor;

wherein the controller, in response to detecting the arrival of the blood sample at the first sensor, ceases its operating of the infusion pump in the rearward direction;

and wherein the signal produced by the first sensor provides an indication of a predetermined parameter of the patient'"'"'s blood when the blood sample is in sensing contact with the first sensor.

23. Apparatus as defined in claim 22, wherein the first sensor of the blood chemistry sensor assembly is selected from the group consisting of a carbon dioxide sensor, an oxygen sensor, a potassium sensor, a calcium sensor, an hematocrit sensor, and a sodium sensor.

24. Apparatus as defined in claim 23, wherein the

the first sensor of the blood chemistry sensor assembly is a carbon dioxide sensor;

the blood chemistry sensor assembly further includes a calcium sensor; and

the controller is configured to detect the arrival of the blood sample at the first sensor in response to a predetermined combination of a first signal generated by the carbon dioxide sensor and a second signal generated by the calcium sensor.

25. Apparatus as defined in claim 22, wherein the first sensor of the blood chemistry sensor assembly is selected from the group consisting of an hematocrit sensor, a temperature sensor, and a pH sensor.

26. Apparatus as defined in claim 22, and further comprising an alarm actuatable in response to a predetermined signal from the first sensor.

27. Apparatus as defined in claim 22, and further comprising an alarm actuatable in response to the absence of a predetermined signal from the first sensor of the blood chemistry sensor assembly within a predetermined time period after the controller initiates its operating of the infusion pump in the reverse direction.

28. Apparatus as defined in claim 22, wherein the controller is configured to cease its operating of the infusion in the reverse direction at a prescribed time after detecting the arrival of the blood sample at the first sensor of the blood chemistry sensor assembly.

29. Apparatus as defined in claim 22, wherein the controller is configured to cease its operating of the infusion pump in the reverse direction after a prescribed additional volume of blood has been drawn from the patient following the detecting of the arrival of the blood sample at the first sensor of the blood chemistry sensor assembly.

30. Apparatus as defined in claim 22, wherein:

the blood chemistry sensor assembly further includes a plurality of sensors in addition to the first sensor, each of the additional sensors producing a signal indicative of a different predetermined parameter of the adjacent fluid; and

the apparatus further comprises a monitor that monitors the signals produced by the plurality of sensors of the sensor assembly, while the blood sample is in sensing contact with the sensors, to produce measurements of a plurality of different predetermined parameters of the patient'"'"'s blood.

31. Apparatus for monitoring a predetermined parameter of patient'"'"'s blood while infusing an infusion fluid into the patient, comprising:

an infusion line and a catheter configured for insertion into a blood vessel of the patient;

a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter;

a blood chemistry senior assembly mounted in flow communication with the infusion line and including first and second sensors that each provide a signal indicative of a different predetermined parameter of any fluid present un the infusion line; and

a controller that operates the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that intermittently interrupts its operating of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a blood sample from the patient through the catheter and infusion line into sensing contact with the first and second sensors of the blood chemistry sensor assembly;

wherein the controller further is configured to monitor the signals provided by the first and second sensors of the blood chemistry sensor assembly and to detect changes in the signals indicative of the arrival of the blood sample at the first and second sensors;

wherein the controller ceases its operating of the infusion pump in the rearward direction in a prescribed manner after detecting the arrival of the blood sample at the first and second sensors and the controller thereafter resumes its operating of the pump in the forward direction, to reinfuse the drawn blood sample back into the patient via the infusion tube and catheter;

and wherein the signal produced by the first sensor provides an indication of a predetermined parameter of the patient'"'"'s blood when the blood sample is in sensing contact with the first sensor.

32. Apparatus as defined in claim 31, wherein the first sensor of the blood chemistry sensor assembly is selected from the group consisting of a carbon dioxide sensor, an oxygen sensor, a potassium sensor, a calcium sensor, an hematocrit sensor, and a sodium sensor.

33. Apparatus as defined in claim 32, wherein;

the first sensor of blood chemistry sensor assembly is a carbon dioxide sensor;

the second sensor of the blood chemistry sensor assembly is a calcium sensor; and

the controller is configured to detect the arrival of the blood sample at the first and second sensors in response to a predetermined combination of a first signal generated by the carbon dioxide sensor and a second signal generated by the calcium sensor.

34. Apparatus as defined in claim 31, wherein the first sensor of the blood chemistry sensor assembly is selected from the group consisting of an hematocrit sensor, a temperature sensor, and a pH sensor.

35. Apparatus as defined in claim 31, and further comprising an alarm actuatable in response to a predetermined signal from the first sensor.

36. Apparatus as defined in claim 31, and further comprising an alarm actuatable in response to the absence of a predetermined signal from the first sensor of the blood chemistry sensor assembly within a predetermined time period after the controller initiates its operating of the infusion pump in the reverse direction.

37. Apparatus as defined in claim 31, wherein the controller is configured to cease its operating of the infusion pump in the reverse direction after a prescribed additional volume of blood has been drawn from the patient following the detecting of the arrival of the blood sample at the first and second sensors of the blood chemistry sensor assembly.

38. Apparatus as defined in claim 31, wherein:

the blood chemistry sensor assembly further includes a plurality of sensors in addition to the first and second sensors, each of the additional sensors producing a signal indicative of a different predetermined parameter of the adjacent fluid; and

the apparatus further comprises a monitor that monitors the signals produced by the plurality of sensors of the sensor assembly, while the blood sample is in sensing contact with the sensors, to produce measurements of a plurality of different predetermined parameters of the patient'"'"'s blood.