Medical infusion controller and user interface

• US 4,634,426 A
• Filed: 12/11/1984
• Issued: 01/06/1987
• Est. Priority Date: 12/11/1984
• Status: Expired due to Fees

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Inventors: Kamen, Dean L.
• Primary Examiner(s): Coven, Edward M.
• Application Number:
  US06/680,500
• Time in Patent Office: 756 Days
• Field of Search: 128/DIG. 13, 604/65, 604/66, 604/67, 604/251, 604/253, 73/861.41, 222/420, 222/422, 250/560
• US Class Current: 604/65
• CPC Class Codes: A61M 5/1689 Drip counters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

An intravenous flow control system includes a programmed microprocessor which receives information from a drop sensor and varies the adjustment of a clamp to control the infusion rate. The system accepts total dose and infusion duration, or dose rate and time information keyed in by the user, and periodically develops a target rate, based on the amount of infusate already delivered, such target rate being calculated to correct the actual delivered dose to that determined by the user keyed data. The target rate differs from the programmed rate by an amount equal to the programmed rate times an adjustment factor. In a preferred embodiment a series of tolerance bands corresponding to delivered volume errors are defined, with the adjustment factor a constant in each tolerance band. For high rate discrepancies, slewing is used to correct the clamp adjustment. Inability to attain the target rate before the delivery of a threshold volume of fluid triggers an alarm. Further alarms are provided for high and low drip rates, streaming, and for deviation of the total volume outside of a progressively defined maximum tolerance band. Control rate and time data are entered by the user through a menu-driven keyboard, in response to displayed messages, thus requiring only INCREASE, DECREASE and SELECT keys.

Claims

1. A medical infusion system for conrolling the flow of fluid from a reservoir through a drip chamber via a flow tube and valve arrangement to a patient, such system comprising:

data entry means for permitting a user to enter desired dose data;

data cumulation means, for storing data entered by the user, for receiving drip detection signals derived from a drip detector, and for cumulating such signals to provide a measure of total delivered volume;

timing means for providing clock signal pulses;

drip rate analysis means, in communication with the timing means, for receiving drip detection signals derived from a drip detector and determinging the current drip rate therefrom;

target rate means, in communication with the timing means and the data cumulation means for repeatedly deriving a target rate to correct the delivered volume at a given time to a volume corresponding to the user-entered data, the target rate means further including means for determining a plurality of volume tolerance bands corresponding to successive ranges of the relative difference between the total delivered volume and the desired volume at a given time, and also includes means for determining the target rate as a function of a program rate determined from the user-entered data, such function being distinct for each tolerance band; and

valve control means, in communication with the the drip rate analysis means and the target rate means, for adjusting the valve so that the current drip rate approaches the target rate.

2. A system according to claim 1, wherein the function of the program rate in each tolerance band is a constant multiple of the program rate in that band.

3. A system according to claim 2, wherein each tolerance band is defined by inner and outer limits, and wherein the constant relating to each such tolerance band is approximately the product of the outer limit of the band and the algebraic sign of the relatively difference.

4. A system according to claim 2, wherein

(i) the system further includes interval signal means for repeatedly generating a run signal at the end of a modifiable predetermined time interval;

(ii) the target rate means is in communication with the interval signal means and includes means for deriving a target rate at the end of the predetermined interval; and

(iii) the system further includes (a) slewing means, for repetitively determining when the current rate differs from the target rate by more than a predetermined amount; and

(b) modifying means, in communication with the slewing means and the interval signal means, for modifying the predetermined interval to a shorter interval, subject to a lower limit, each time the slewing means determines that current rate differs from the target rate by more than the predetermined amount.

5. A system according to claim 3, wherein the outer limit of a band is approximately twice the inner limit thereof.

6. A system according to claim 5, including tolerance bands defined by approximate inner and outer limits of relative difference of 0% and 2.5%, 2.5% and 5%, 5% and 10%, 10% and 25%, and 25% and 50%.

7. A system according to claim 1, wherein

(i) the system further includes interval signal means for repeatedly generating a run signal at the end of a modifiable predetermined time interval;

(ii) the target rate means is in communication with the interval signal means and includes means for deriving a target rate at the end of the predetermined interval; and

(iii) the system further includes (a) slewing means, for repetitively determining when the current rate differs from the target rate by more than a predetermined amount; and

(b) modifying means, in communication with the slewing means and the interval signal means, for modifying the predetermined interval to a shorter interval, subject to a lower limit, each time the slewing means determines that current rate differs from the target rate by more than the predetermined amount.

8. A medical infusion system for controlling the flow of fluid from a reservoir through a drip chamber via a flow tube and valve arrangement to a patient, such system comprising:

data entry means for permitting a user to enter desired dose data;

data cumulation means, for storing data entered by the user, for receiving drip detection signals derived from a drip detector, and for cumulating such signals to provide a measure of total delivered volume, the data cumulation means further comrising queue means, in communication with the timing means, for cumulating data signals representative of the time of occurrence of a predetermined number of consecutive drip detection signals, such predetermined number being a variable increasing function of the magnitude of the drip rate;

timing means for providing clock signal pulses;

drip rate analysis means, in communication with the timing means, for receiving drip detection signals derived from a drip detector and determining the current drip rate therefrom, the drip rate analysis means further including means in communication with the queue means for determining the average drip rate of the predetermined number of drops from the data signals in the queue;

so that a stable measure of drip rate is provided, irrespective of changes in the relative magnitude of the drip rate;

target rate means, in communication with the timing means and the data cumulation means for repeatedly deriving a target rate to correct the delivered volume at a given time to a volume corresponding to the user-entered data; and

valve control means, in communication with the the drip rate analysis means and the target rate means, for adjusting the valve so that the current drip rate approaches the target rate.

9. A system according to claim 8, wherein the predetermined number is approximately equal to C+[R/30], where C is a constant, and R denotes the drip rate in drops per minute and the brackets [] define a step function denoting the greatest integer less than the bracketed quantity.

10. A system according to claim 9, wherein C=2.

11. A system according to claim 8, comprising:

(i) occlusion number means in communication with the drip rate analysis means for repeatedly determining an occlusion number as a function of the current drip rate; and

(ii) resettable occlusion time counter means, in communication with the occlusion number means and the timing means, for decrementing the occlusion number upon each clock signal pulse and for providing an alarm signal when the occlusion number has been decremented to a threshold, such means being reset to a new occlusion number on receipt of a drip detection signal if the alarm signal has not been provided.

12. A system according to claim 11, wherein the occlusion number is inversely proportional to 2^QCNT +D where QCNT is the predetermined number and D is a constant.

13. A system according to claim 12, wherein D is approximately 6.

14. A medical infusion system for controlling the flow of fluid from a reservoir through a drip chamber via a flow tube and valve arrangement to a patient, such system comprising:

data entry means for permitting a user to enter desired dose data;

data cumulation means, for storing data entered by the user, for receiving drip detection signals derived from a drip detector, and for cumulating such signals to provide a measure of total delivered volume;

timing means for providing clock signal pulses;

drip rate analysis means, in communication with the timing means, for receiving drip detection signals derived from a drip detector and determining the current drip rate therefrom;

target rate means, in communication with the timing means and the data cumulation means for repeatedly deriving a target rate to correct the delivered volume at a given time to a volume corresponding to the user-entered data;

valve control means, in communication with the the drip rate analysis means and the target rate means, for adjusting the valve so that the current drip rate approaches the target rate;

occlusion number means in communication with the drip rate analysis means for repeatedly determining an occlusion number as a function of the current drip rate; and

resettable occlusion time counter means, in communication with the occlusion number means and the timing means, for decrementing the occlusion number upon each clock signal pulse and for providing an alarm signal when the occlusion number has been decremented to a threshold, such means being reset to a new occlusion number on receipt of a drip detection signal if the alarm signal has not been provided.