IV administration set infiltration monitor

• US 5,213,573 A
• Filed: 08/05/1991
• Issued: 05/25/1993
• Est. Priority Date: 08/05/1991
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMED Corp (Becton, Dickinson & Co)
• Inventors: Burkett, David, Sorich, Richard A.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): JONES, MARYBETH O
• Application Number:
  US07/741,257
• Time in Patent Office: 659 Days
• Field of Search: 604/65, 604/66, 604/67, 604/250, 604/251, 604/153, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/66
• 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

An apparatus for determining whether an IV infusion set has infiltrated the tissue of a patient includes a pump for pumping fluid through the IV set into the patient and a pressure transducer operably engaged with the IV set between the pump and patient. The pressure transducer is electrically connected to a microprocessor, and the microprocessor is electrically connected to the motor of the pump to control the pump to alternately withdraw from and infuse into the patient a predetermined volume of fluid.

This predetermined volume of fluid is withdrawn from the patient by the pump at a preselected withdrawal pressure, while the pump infuses the predetermined volume of fluid into the patient at a preselected infusion pressure. The microprocessor measures both the time period for infusing the predetermined volume of fluid and the time period for withdrawing the predetermined volume of fluid. Based upon these time periods, the microprocessor evaluates whether the IV set has infiltrated the patient'"'"'s tissue.

Claims

1. An apparatus for determining abnormal fluid flow through an IV administration set, which comprises:

an IV fluid tube connectable in fluid communication with the patient;

a pump operatively engaged with said tube for causing fluid to flow through said tube;

a pressure sensor operatively engaged with said tube between said pump and the patient for determining fluid pressure in said IV fluid tube;

means electrically connected to said pressure sensor for operating said pump for withdrawing fluid having first flow characteristics from the patient and for operating said pump for infusing fluid having second flow characteristics to the patient, wherein said operating means causes said pump to withdraw a first volume of fluid from said vessel of the patient at a preselected withdrawal pressure during a first predetermined time interval, and said operating means causes said pump to infuse a second volume of fluid into said vessel of the patient at a preselected infusion pressure during a second predetermined time interval; and

means for evaluating said first characteristics and said second characteristics to determine whether said IV administration set is infiltrated into the patient'"'"'s tissue.

2. An apparatus as recited in claim 1 wherein said evaluating means compares said first time interval with said second time interval to determine whether said IV administration set is infiltrated.

3. An apparatus as recited in claim 2 wherein said preselected pressure for infusing fluid to the patient equals a datum pressure plus a differential pressure and said preselected pressure for withdrawing fluid from the patient equals said datum pressure minus said differential pressure.

4. An apparatus as recited in claim 3 wherein said differential pressure is approximately equal to one half pounds per square inch (0.5 psi).

5. An apparatus as recited in claim 2 wherein said predetermined volume of fluid is approximately equal to fifteen microliters (15 μ

l).

6. An apparatus as recited in claim 2 wherein said pump is a peristaltic pump for generating a moving zone of occlusion along said IV tube and said pressure sensor is located between said moving zone of occlusion and the patient during said first time interval and during said second time interval.

7. An apparatus as recited in claim 2 wherein said pump is operated in a reverse mode during said first time interval and is operated in a forward mode during said second time interval.

8. An apparatus as recited in claim 2 wherein said means for operating said pump is a stepper motor and said predetermined volume of fluid is correlated to a number of incremental steps of operation of said stepper motor.

9. An apparatus as recited in claim 2 further comprising means to alarm when said evaluating means compares said first time interval with said second time interval and determines that said IV administration set is infiltrated.

10. An apparatus as recited in claim 2 further comprising means to alarm when said evaluating means forms a ratio of said first time interval to said second time interval and exceeds a predetermined value.

11. An apparatus as recited in claim 1 wherein said evaluating means compares said first volume to said second volume to determine whether said IV administration set is infiltrated.

12. A method for determining whether there is abnormal fluid flow through an IV administration set, the set including a fluid source in fluid communication with a patient through an IV fluid tube and a pumping mechanism operatively engaged with the IV tube for pumping fluid through the IV tube, which comprises the steps of:

operating said pumping mechanism to withdraw fluid having withdrawal fluid flow characteristics from the patient, wherein said step of operating the pumping mechanism to withdraw fluid comprises withdrawing a first fluid volume of fluid from the patient at a preselected pressure during a predetermined time;

measuring selected components of said withdrawal fluid flow characteristics;

operating said pumping mechanism to infuse fluid having infusion fluid flow characteristics to the patient, wherein said step of operating said pumping mechanism to infuse fluid comprises infusing a second volume of fluid to the patient at a preselected pressure during a predetermined time interval;

measuring selected components of said infusion fluid flow characteristics; and

comparing said selected components of said withdrawal fluid flow characteristics with said selected components of said infusion fluid flow characteristics for determining whether said IV administration set is experiencing abnormal fluid flow, wherein said step of comparing comprises comparing said first and said second volumes to determine whether there is abnormal fluid flow through said IV administration set.

13. An apparatus for determining abnormal fluid flow through an IV administration set, which comprises:

an IV fluid tube connectable in fluid communication with a patient;

a pump operatively engaged with said tube for causing fluid to flow through said tube;

a pressure sensor operatively engaged with said tube between said pump and the patient for determining fluid pressure in said IV fluid tube;

means electrically connected to said pressure sensor for operating said pump for withdrawing fluid having first flow characteristics from the patient and for operating said pump for infusing fluid having second flow characteristics to the patient, wherein said operating means causes said pump to infuse a predetermined volume of fluid to the patient during a predetermined time interval at an infusion pressure, and said operating means causes said pump to withdraw a predetermined volume of fluid from the patient during a predetermined time interval at a withdrawal pressure; and

means for evaluating said first characteristics and said second characteristics to determine whether said IV administration set is infiltrated into the patient'"'"'s tissue.

14. An apparatus as recited in claim 13 wherein said evaluating means compares said infusion pressure to said withdrawal pressure to determine whether said IV administration set is infiltrated.

15. A method for determining whether there is abnormal fluid flow through an IV administration set, the set including a fluid source in fluid communication with a patient through an IV fluid tube and a pumping mechanism operatively engaged with the IV tube for pumping fluid through the IV tube, which comprises the steps of:

operating said pumping mechanism to withdraw a predetermined volume of fluid from the patient at a first pressure during a predetermined time interval, and operating said pumping mechanism to infuse a predetermined volume of fluid to the patient at a second pressure during a predetermined time period, and comparing such first and second pressures to determine whether there is abnormal fluid flow through said IV administration set.