Method and apparatus for infiltration detection during administration of intravenous fluids

• US 5,423,746 A
• Filed: 05/24/1993
• Issued: 06/13/1995
• Est. Priority Date: 08/05/1991
• Status: Expired due to Fees

• Current Assignee: Alaris Medical Inc (Becton, Dickinson & Co)
• Original Assignee: IMED Corp (Becton, Dickinson & Co)
• Inventors: Kaplan, David E., Burkett, David H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/066,679
• Time in Patent Office: 750 Days
• Field of Search: 604/19, 604/21, 604/27, 604/28, 604/30, 604/34, 604/65, 604/67, 604/66, 604/246, 128/DIG. 13
• US Class Current: 604/65
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A method for testing for patency at a venous access site during intravenous infusion of a medical solution includes the steps of occluding an intravenous injection tube upstream from the venous access site and monitoring the time and fluid pressure within the tube while the fluid pressure within the tube is varied by external contact with the tube. An apparatus for practicing the method of the invention includes a housing formed with a tube receiving portion for holding a portion of the tube in contact with an occluder finger, a fluid moving finger and a pressure transducer. The fluid moving finger is adapted to contact the tube so as to achieve a testing base pressure in the fluid, after occlusion by the occluder finger. A sequence of pressure drops are then effected by moving the fluid moving finger in stepped increments. An excessive time interval between a pressure drop and a recovery of fluid pressure back to the testing base pressure is an indication of an infiltration condition or some other obstruction.

Claims

1. An apparatus for detecting the presence of an obstruction or infiltration of a fluid being delivered through an intravenous tube to a patient, comprising:

occlusion means for occluding an intravenous tube at a first location;

fluid moving means for subjecting the fluid downstream of said first location to a pressure drop below a first pressure level;

pressure monitoring means in contact with an exterior surface of the tube for monitoring fluid pressure within the tube downstream of said first location;

processing means in communication with said occlusion means, said fluid moving means, and said pressure monitoring means, for controlling said occlusion means to occlude the tube, for controlling said fluid moving means to subject the fluid to said pressure drop, for measuring a recovery time interval required for the pressure in the tube to recover to said first pressure level, and for comparing said recovery time interval with a predetermined time interval; and

display means connected to said processing means for indicating the results of said comparison.

2. The apparatus as recited in claim 1, wherein said occlusion means comprises an occlusion finger for contacting and occluding the tube.

3. The apparatus as recited in claim 2, wherein said occlusion finger pinches the tube against a platen.

4. The apparatus as recited in claim 1, wherein said fluid moving means comprises a fluid moving finger for partially occluding the tube and adapted to be incrementally withdrawn from the tube a predetermined distance to initiate said pressure drop.

5. The apparatus as recited in claim 1, wherein said fluid moving means is adapted to initiate a plurality of pressure drops in a predetermined time period.

6. The apparatus as recited in claim 1, wherein said fluid moving means is adapted to achieve said first pressure level as a testing base pressure that is a selected amount below a stable pressure existing in the tube after occlusion by said occlusion means.

7. The apparatus as recited in claim 1, wherein said pressure monitoring means comprises a pressure transducer.

8. The apparatus as recited in claim 1, wherein said display means comprises an audible alarm.

9. The apparatus as recited in claim 1, wherein said display means comprises a display light.

10. The apparatus as recited in claim 1, further comprising switching means for controlling operation of said apparatus responsive to introduction of a supplemental fluid into the tube.

11. The apparatus as recited in claim 10, wherein the control exercised by said switching means is interruption of the operation of said apparatus during introduction of the supplemental fluid.

12. The apparatus as recited in claim 10, wherein the control exercised by said switching means is initiation of operation of said occlusion means, said fluid moving means, said pressure monitoring means, and said processing means upon cessation of introduction of the supplemental fluid.

13. An infiltration detection apparatus for monitoring an intravenous infusion procedure in which a fluid is infused into a patient using a tube in fluid communication with a blood vessel of the patient, comprising;

a housing formed with a tube receiving portion for receiving and retaining a portion of an intravenous tube;

an occluder finger reciprocally mounted at a first location within said housing for movement by a first stepper motor to occlude the tube held in said tube receiving portion;

a fluid moving finger mounted downstream of said first location in external contact with the tube within said housing, adapted for reciprocal movement by a second stepper motor, to achieve a pressure drop in the tube to a testing base pressure and to achieve a subsequent pressure drop in the tube by movement away from the tube;

a pressure transducer mounted within said housing in contact with the tube for monitoring the pressure of the fluid within the tube downstream of said first location;

a control circuit mounted within said housing, including a microprocessor electrically connected to said pressure transducer and to said first and second stepper motors, with said microprocessor adapted to control said occluder finger to occlude the tube and to control said fluid moving finger to achieve said testing base pressure and to initiate said subsequent pressure drop in the tube, with said microprocessor adapted to time a period for the pressure in the tube to return to said testing base pressure after said subsequent pressure drop, and with said microprocessor adapted to compare said time period with a predetermined time period; and

display means connected to said control circuit for indicating the results of said comparison of said time periods.

14. The apparatus as recited in claim 13, wherein said microprocessor is adapted to time an interval for achieving a stable pressure in the tube after occlusion by said occluder finger.

15. The apparatus as recited in claim 13, wherein said microprocessor is adapted to time an interval for achieving said testing base pressure.

16. The apparatus as recited in claim 13, wherein said display means includes an audible alarm.

17. The apparatus as recited in claim 13, wherein said display means includes a display light.

18. The apparatus as recited in claim 13, wherein said tube receiving means includes a door mounted to said housing for loading the tube in a position in contact with said fluid moving finger and said pressure transducer.

19. The apparatus as recited in claim 13, wherein said fluid moving finger is adapted to achieve said testing base pressure in the tube about 0.5 psi below a stable pressure remaining in the tube after occlusion by said occluder finger.

20. The apparatus as recited in claim 13, further comprising a switch for controlling operation of said apparatus responsive to introduction of a supplemental fluid into said tube.

21. The apparatus as recited in claim 20, wherein the control exercised by said switch is interruption of the operation of said apparatus during introduction of the supplemental fluid,

22. The apparatus as recited in claim 20, wherein the control exercised by said switch is initiation of operation of said occluder finger, said fluid moving finger, said pressure transducer, and said microprocessor upon cessation of introduction of the supplemental fluid.

23. The apparatus as recited in claim 20, wherein said switch is a pressure sensitive switch shaped to fit between the thumb of an operator and a plunger of a syringe being used to introduce the supplemental fluid.

24. A method of monitoring an intravenous fluid infusion procedure to test for a patency condition at the venous access site, comprising the steps of:

occluding an intravenous fluid infusion tube upstream from the venous access site;

manipulating an external surface of said tube to achieve a testing base pressure;

initiating a pressure drop in the fluid within said tube by manipulating said external surface of said tube;

sensing pressure in the fluid within said tube by contact with said external surface of said tube;

timing an interval between said pressure drop and a recovery of said pressure in the fluid to said testing base pressure;

comparing said time interval with a predetermined time limit; and

displaying an alarm if said time interval is greater than said predetermined time limit.

25. The method as recited in claim 24, wherein said testing base pressure is about 0.5 psi below a stable pressure remaining in the fluid after occluding said tube.

26. The method as recited in claim 24, further comprising the steps of:

timing a second interval between occluding said tube and sensing a stable pressure in the fluid; and

displaying an indicator of an unsatisfactory condition if said second time interval is greater than a second predetermined time limit.

27. The method as recited in claim 24, further comprising the steps of:

timing a second interval between manipulating said tube to achieve said testing base pressure and sensing said testing base pressure in the fluid; and

displaying an indicator of an unsatisfactory condition if said second time interval is greater than a second predetermined time limit.

28. The method as recited in claim 24, further comprising the steps of:

initiating a sequence of a plurality of pressure drops in the fluid, with each said drop followed by a recovery of pressure in the fluid to said testing base pressure;

timing a second interval for completion of said sequence; and

displaying an indicator of an unsatisfactory condition if said second time interval is greater than a second predetermined time limit.