Cannula position detection

• US 5,423,743 A
• Filed: 09/17/1993
• Issued: 06/13/1995
• Est. Priority Date: 09/17/1993
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Butterfield, Robert D.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/123,327
• Time in Patent Office: 634 Days
• Field of Search: 128/DIG. 12, 128/DIG. 13, 604/65-67, 604/50, 604/118, 604/244, 604/245, 604/49, 604/50
• US Class Current: 604/505
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

Bidirectional flow patterns are induced in a fluid supply line and the reverse flow resistance and the forward flow resistance are measured and compared. A measure of the resistance to flow is made by normalizing a sum of the entire pressure response about a pressure baseline according to the volume of fluid in the bidirectional flow pattern. In the event that the cannula is positioned near or against the vessel wall, the resulting relatively large negative pressure response can indicate the positional irregularity. In one embodiment, a time period of zero flow is included between the positive and negative flow volumes to permit the system to stabilize.

Claims

1. A method for determining the position of a cannula inserted into the vascular system of a patient, the cannula coupled to the downstream end of a conduit that is connected at its upstream end to a reservoir of fluid, the method comprising the steps of:

a. establishing a baseline pressure based on the pressure in the conduit when no flow of fluid is occurring;

b. moving a first predetermined quantity of fluid towards the upstream end of the conduit;

c. measuring the pressure in the conduit during the step of moving the predetermined quantity of fluid towards the upstream end;

d. moving a second predetermined quantity of fluid towards the downstream end of the conduit;

e. measuring the pressure in the conduit during the step of moving the predetermined quantity of fluid towards the downstream end;

f. summing the differences between the measured pressures and the baseline pressure;

g. normalizing the pressure difference sum by the predetermined quantity of fluid;

h. comparing the normalized sum to a predetermined range; and

i. providing an alarm if the normalized sum is outside the predetermined range

j. wherein steps (a), (f), (g), (h), and (i) are performed by a processor.

2. The method of claim 1 wherein the step of establishing the baseline pressure comprises the steps of:

establishing a downstream delivery flow of the fluid through the conduit into the patient;

stopping the delivery flow through the conduit for a first predetermined time period before the step of moving the predetermined quantity of fluid towards the upstream end;

measuring the pressure during the first predetermined time period;

stopping the delivery flow through the conduit for a second predetermined time period after the step of moving the predetermined quantity of fluid towards the downstream end;

measuring the pressure during the second predetermined time period; and

determining the baseline pressure by the processor by taking the average of the pressures during the first and second predetermined time periods.

3. The method of claim 1 further comprising the steps of:

repeating steps a. through g. at least once;

by the processor filtering the normalized pressure difference sums over the number of times steps a. through g. were repeated to provide a filtered normalized sum;

conducting step h. on the filtered normalized sums; and

wherein step i provides the alarm only if the filtered normalized sum is outside the predetermined range.

4. The method of claim 3 wherein the step of filtering by the processor comprises one of the steps selected from the group consisting of:

averaging the normalized pressure difference sums;

taking a sliding average of the normalized pressure difference sums;

filtering the normalized pressure difference sum with a finite impulse response filter;

filtering the normalized pressure difference sum with an infinite impulse response filter; and

taking a least squares fit of the normalized pressure difference sums.

5. The method of claim 1 further comprising the step of stopping the normal flow through the conduit for a selected time period between the steps of moving the predetermined quantity of fluid towards the upstream end and the step of moving the predetermined quantity of fluid towards the downstream end of the conduit.

6. The method of claim 5 wherein the step of stopping the flow for a selected time period comprises the step of selecting the time period to be long enough for the pressure in the conduit to stabilize.

7. The method of claim 1 wherein the step of providing an alarm by the processor comprises the steps of:

repeating steps a. through h. again if the normalized sum is outside the predetermined range; and

providing an alarm only if after steps a. through h. have been repeated, the normalized sum remains outside the predetermined range.

8. The method of claim 1 wherein the step of summing by the processor comprises the steps of:

computing the sum of the difference between the measured pressure during the upstream flow of the predetermined quantity of fluid and the baseline pressure;

computing the sum of the difference between the measured pressure during the downstream flow of the predetermined quantity and the baseline pressure; and

summing the computed sums.

9. The method of claim 1 further comprising the step of applying a pump to the conduit to perform the steps of moving the predetermined quantity of fluid, the pump being adapted for occluding the conduit at all times;

and

wherein the steps of measuring the pressure in the conduit comprise measuring the pressure in the conduit at a point between the cannula and the point of occlusion provided by the pump.

10. The method of claim 9 comprising the steps of:

stopping the pump for a first time period and measuring the pressure in the conduit during this time period;

pumping the predetermined quantity of fluid towards the upstream end of the conduit in a second time period which occurs after the first time period;

stopping the pump for a third time period to establish a predetermined pressure level, the third time period occurring after the second;

pumping the predetermined quantity of fluid towards the downstream end of the conduit in a fourth time period, the fourth period following the third period;

stopping the pump for a fifth time period and measuring the pressure in the conduit during this time period, the fifth period occurring after the fourth period;

wherein the step of establishing the baseline pressure by the processor comprises the step of averaging the pressures measured during the first and fifth time periods; and

the step of summing comprises summing by the processor the pressures measured during the second and fourth time periods.

11. The method of claim 1 wherein the first and second predetermined quantities of fluid are equal.

12. A method for determining the position of a cannula inserted into the vascular system of a patient, the cannula coupled to the downstream end of a conduit that is connected at its upstream end to a reservoir of fluid, the method comprising the steps of:

a. moving a predetermined quantity of fluid towards the upstream end of the conduit;

b. measuring the pressure in the conduit during the step of moving the predetermined quantity of fluid towards the upstream end;

c. moving the predetermined quantity of fluid towards the downstream end of the conduit;

d. measuring the pressure in the conduit during the step of moving the predetermined quantity of fluid towards the downstream end;

e. computing the reverse resistance to the movement of the quantity of fluid towards the upstream end of the conduit based on the pressure measured during the step of moving the predetermined quantity of fluid towards the upstream end;

f. computing the forward resistance to the movement of the quantity of fluid towards the downstream end based on the step of moving the predetermined quantity of fluid towards the downstream end;

g. taking the difference between the forward resistance and the reverse resistance; and

h. providing an alarm if the resistance difference is outside a predetermined range

j. wherein steps (e), (f), (g), and (h) are performed by a processor.

13. The method of claim 12 further comprising the step of establishing a baseline pressure by the processor based on the pressure in the conduit when no flow is occurring through the conduit;

and

wherein the steps of computing by the processor include summing the measured pressures about the baseline pressure.

14. The method of claim 13 wherein the step of establishing the baseline pressure by the processor comprises the steps of:

establishing a downstream delivery flow of the fluid through the conduit into the patient;

stopping the delivery flow through the conduit for a first predetermined time period before the step of moving the first predetermined quantity of fluid towards the upstream end of the conduit;

measuring the pressure during the first predetermined time period;

stopping the delivery flow through the conduit for a second predetermined time period after the step of moving the second predetermined quantity of fluid towards the downstream end;

measuring the pressure during the second predetermined time period; and

determining the baseline pressure by taking the average of the pressures during the first and second predetermined time periods.

15. The method of claim 12 further comprising:

repeating steps a. through g. at least once;

filtering the resistance differences by the processor over the number of times steps a. through g. were repeated to provide a filtered resistance difference; and

conducting step h. only on the filtered resistance difference.

16. The method of claim 15 wherein the step of filtering by the processor comprises the step of averaging the resistance differences.

17. The method of claim 15 wherein the step of providing an alarm by the processor comprises the steps of:

repeating steps a. through g. again if the filtered resistance difference is outside the predetermined range; and

providing an alarm only if after the steps having been repeated, the filtered resistance difference remains outside the range.

18. The method of claim 12 further comprising the step of stopping the normal flow through the conduit for a selected time period between the steps of moving the predetermined quantity of fluid towards the upstream end of the conduit and the step of moving the predetermined quantity of fluid towards the downstream end of the conduit.

19. The method of claim 18 wherein the step of stopping the flow for a selected time period comprises the step of selecting the time period to be long enough for the pressure in the conduit to stabilize.

20. The method of claim 12 further comprising the step of applying a pump to the conduit to perform the steps of moving the predetermined quantity of fluid, the pump being adapted for occluding the conduit at all times;

and

wherein the steps of measuring the pressure in the conduit comprise measuring the pressure at a conduit location between the cannula and the point of occlusion provided by the pump.

21. The method of claim 20 further comprising the steps of:

stopping the pump for a first time period and measuring the pressure in the conduit during this time period;

pumping the predetermined quantity of fluid towards the upstream end of the conduit in a second time period which occurs after the first time period;

stopping the pump for a third time period to establish a predetermined pressure level, the third time period occurring after the second;

pumping the predetermined quantity of fluid towards the downstream end of the conduit in a fourth time period, the fourth period following the third period;

stopping the pump for a fifth time period and measuring the pressure in the conduit during this time period, the fifth period occurring after the fourth period;

wherein the step of computing the reverse resistance by the processor includes basing the computation on the pressure sensed during the second time period; and

wherein the step of computing the forward resistance by the processor includes basing the computation on the pressure sensed during the fourth time period.

22. The method of claim 21 further comprising the step of establishing a baseline pressure by the processor based on the pressure in the conduit during the first and fifth time periods;

and

wherein the steps of computing by the processor include summing the measured pressures about the baseline pressure.

23. A system for determining the position of a cannula inserted into the vascular system of a patient, the cannula coupled to the downstream end of a conduit that is connected at its upstream end to a reservoir of fluid and a flow control device engaged with the conduit to control the flow of fluid through the conduit, the flow control device occluding the conduit continuously, the system comprising:

a pressure sensor for communication with the fluid in the conduit downstream of the occlusion provided by the flow control device, the pressure sensor for providing a pressure signal representative of the pressure of the fluid;

a processor for;

receiving the pressure signal provided by the pressure sensor;

controlling the flow control device to stop flow in the conduit and establish a baseline pressure based on the pressure signal received from the pressure sensor during this period of stopped flow;

controlling the flow control device to move a first predetermined quantity of fluid in the conduit in an upstream direction and a second predetermined quantity of fluid in a downstream direction;

summing the differences between the pressure signals received from the pressure sensor during the upstream and the downstream flows of the predetermined quantity of fluid and the baseline pressure;

normalizing the pressure difference sum by the predetermined quantity of fluid; and

providing an alarm if the normalized sum is outside a predetermined range.

24. The system of claim 23 wherein the processor is further connected to:

control the flow control device to stop flow through the conduit before and after it has moved the predetermined quantity of fluid in an upstream direction and in a downstream direction;

receive the pressure signals provided by the pressure sensor during these periods of stopped flow; and

determine the baseline pressure by averaging the pressure signals received during the periods of stopped flow.

25. The system of claim 23 wherein the processor is connected to:

control the flow control device to move the predetermined quantity of fluid in the conduit in an upstream direction and in a downstream direction multiple times;

sum the differences between the baseline pressure and the pressure signals received from the pressure sensor during the upstream flow and the downstream flow for each repetition;

normalize each pressure difference sum by the predetermined quantity of fluid for each repetition;

filter the normalized pressure difference sums over the number of multiple times to provide a filtered normalized sum; and

provide the alarm only if the filtered normalized sum is outside the predetermined range.

26. The system of claim 25 wherein the processor is further connected to determine the average of the normalized pressure difference sums as the filtered normalized sum.

27. The system of claim 23 wherein the processor is further connected to stop the flow of fluid through the conduit for a first selected time period between the period of moving the predetermined quantity of fluid towards the upstream end and the period of moving the predetermined quantity of fluid towards the downstream end of the conduit.

28. The system of claim 27 wherein the processor selects the first time period to be long enough for the pressure in the conduit to stabilize.

29. The system of claim 23 wherein the processor is further connected to:

control the flow control device to repeat the movements of the predetermined quantity of fluid in the conduit in the upstream direction and in the downstream direction for at least one additional time if the normalized sum is outside the predetermined range;

sum the differences for each repetition between the baseline pressure and the pressure signals received from the pressure sensor during the upstream and the downstream flows;

normalize each pressure difference sum by the predetermined quantity of fluid for each respective repetition; and

.

provide the alarm only if the normalized sum of one or more repetitions remains outside the predetermined range.

30. The system of claim 23 wherein as part of the sum of the differences, the processor is further connected to:

compute the sum of the difference between the measured pressure during the upstream flow of the predetermined quantity of fluid and the baseline pressure;

compute the sum of the difference between the measured pressure during the downstream flow of the predetermined quantity and the baseline pressure; and

sum the computed sums.

31. The system of claim 23 wherein the processor is further connected to:

stop the flow control device for a first time period and measure the pressure in the conduit during this time period;

pump the first predetermined quantity of fluid towards the upstream end of the conduit in a second time period which occurs after the first time period;

stop the flow control device for a third time period to establish a predetermined pressure level, the third time period occurring after the second;

pump the second predetermined quantity of fluid towards the downstream end of the conduit in a fourth time period, the fourth period following the third period;

stop the flow control device for a fifth time period and measure the pressure in the conduit during this time period, the fifth period occurring after the fourth period;

establish the baseline pressure by averaging the pressures measured during the first and fifth time periods; and

sum the differences between the pressure signals measured during the second and fourth time periods and the baseline pressure.

32. The system of claim 23 wherein the first and second predetermined quantities of fluid are equal.

33. A system for determining the position of a cannula inserted into the vascular system of a patient, the cannula coupled to the downstream end of a conduit that is connected at its upstream end to a reservoir of fluid and a flow control device engaged with the conduit to control the flow of fluid through the conduit, the flow control device occluding the conduit continuously, the system comprising:

a pressure sensor for communication with the fluid in the conduit downstream of the occlusion provided by the flow control device, the pressure sensor for providing a pressure signal representative of the pressure of the fluid;

a processor for;

receiving the pressure signal provided by the pressure sensor;

controlling the flow control device to move a predetermined quantity of fluid in the conduit in an upstream direction and in a downstream direction;

computing the reverse resistance to the movement of the quantity of fluid towards the upstream end of the conduit based on the pressure signal received during the movement;

computing the forward resistance to the movement of the quantity of fluid towards the downstream end of the conduit based on the pressure signals received during the movement;

determining the difference between the forward resistance and the reverse resistance; and

providing an alarm if the resistance difference is outside a predetermined range.

34. The system of claim 33 wherein the processor is further connected to:

establish a baseline pressure based on the pressure in the conduit when no flow of fluid is occurring through the conduit; and

numerically sum the measured pressures about the baseline pressure when computing the resistances.

35. The system of claim 34 wherein the processor is further connected to:

establish a downstream delivery flow of the fluid through the conduit into the patient;

stop the delivery flow through the conduit for a first predetermined time period before moving the predetermined quantity of fluid towards the upstream end of the conduit;

measure the pressure during the first predetermined time period;

stop the delivery flow through the conduit for a second predetermined time period after moving the predetermined quantity of fluid towards the downstream end;

measure the pressure during the second predetermined time period; and

determine the baseline pressure by averaging the pressures during the first and second predetermined time periods.

36. The system of claim 34 wherein the processor is further connected to:

stop the flow control device for a first time period and measure the pressure in the conduit during this time period;

pump the predetermined quantity of fluid towards the upstream end of the conduit in a second time period which occurs after the first time period;

stop the flow control device for a third time period to establish a predetermined pressure level, the third time period occurring after the second;

pump the predetermined quantity of fluid towards the downstream end of the conduit in a fourth time period, the fourth period following the third period;

stop the flow control device for a fifth time period and measure the pressure in the conduit during this time period, the fifth period occurring after the fourth period;

establish the baseline pressure based on the pressures measured during the first and fifth time periods;

compute the reverse resistance based on the pressure sensed during the second time period; and

compute the forward resistance based on the pressure sensed during the fourth time period.

37. The system of claim 33 wherein the processor is further connected to:

repeat the movement of the predetermined quantity of fluid in the upstream and downstream directions at least once;

filter the resistance differences over the number of repetitions to provide a filtered resistance difference;

compute the reverse and forward resistances for each repetition;

determine the resistance difference for each repetition; and

provide the alarm only if the filtered resistance difference is outside the predetermined range.

38. The system of claim 37 wherein the processor is further connected to determine the average of the resistance differences as the filtered resistance difference.

39. The system of claim 33 wherein the processor is further connected to:

control the flow control device to repeat the movements of the predetermined quantity of fluid in the conduit in the upstream direction and in the downstream direction for at least one additional time if the resistance difference is outside the predetermined range;

compute the reverse and forward resistances for each repetition;

determine the resistance difference for each repetition; and

provide the alarm only if the resistance difference of one or more repetitions remains outside the predetermined range.

40. The system of claim 33 wherein the processor is further connected to stop the flow through the conduit for a first selected time period between moving the predetermined quantity of fluid towards the upstream end of the conduit and moving the predetermined quantity of fluid towards the downstream end of the conduit.

41. The system of claim 40 wherein the processor selects the first time period to be long enough for the pressure in the conduit to stabilize.