Pressure (occlusion) sensor

• US 5,989,222 A
• Filed: 06/12/1998
• Issued: 11/23/1999
• Est. Priority Date: 06/12/1998
• Status: Expired due to Term

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Abbott Laboratories
• Inventors: Lawless, Michael W., Soberon, Peter A., Lynch, Christopher D., Mo, Frank S. C., Cole, Martin A.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): ROBERT, EDUARDO C
• Application Number:
  US09/097,062
• Time in Patent Office: 529 Days
• Field of Search: 604/151, 604/152, 604/65, 604/66, 604/67, 128/DIG. 13
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A system and a method for detecting the presence of an occlusion in an intravenous (IV) line supplying a medicinal liquid to a patient. Two pressure occlusion sensors are employed to produce a value for the proximal and distal pressures within an IV pumping cassette that is disposed in the fluid path of the IV line. Each pressure occlusion sensor includes a strain gauge connected to a leaf spring that is fixed at one end within a pump chassis and a rod that is disposed transverse to the leaf spring. Each rod has one end that responds to the force of a portion of an elastomeric membrane inside the pumping cassette and another end that contacts a free end of the leaf spring. When a leaf spring is flexed by the movement of a rod, the strain gauge mounted on the leaf spring produces a differential voltage that corresponds to a fluid pressure within the pumping cassette. The distal pressure occlusion sensor automatically opens a flow stop on the pumping cassette when the pumping cassette is inserted into the pump chassis. The outputs from the distal and proximal pressure sensors are sampled at least once per second to ensure that maximum pressure values are not exceeded and that a pressure sensor failure is immediately detected.

Claims

1. A system for detecting an impediment to a fluid flow through an intravenous line, comprising:

(a) a pump chassis;

(b) a pump in fluid communication with the intravenous line and mountable within the pump chassis to receive a driving force, said pump including a proximal port, a distal port, and an elastomeric membrane overlying a fluid path through the fluid pump adjacent the proximal port and distal port;

(c) a proximal pressure sensor mounted on the pump chassis and including a member that is coupled to the elastomeric membrane adjacent to the proximal port of the pump and responsive to a deflection and force exerted by the elastomeric membrane due to a proximal fluid pressure within the pump, producing a proximal pressure signal indicative thereof;

(d) a distal pressure sensor mounted on the pump chassis and including a member that is coupled to the elastomeric membrane adjacent to the distal port of the pump and responsive to a deflection and force exerted by the elastomeric membrane due to a distal fluid pressure within the pump, producing a distal pressure signal indicative thereof; and

(e) a controller that is electrically coupled to the proximal pressure sensor and the distal pressure sensor to receive the proximal and distal pressure signals, said controller employing the proximal pressure signal to determine a baseline proximal pressure and an absolute proximal pressure, and employing the distal pressure signal to determine a baseline distal pressure and an absolute distal pressure, and determining whether an impediment to fluid flow through the intravenous line has occurred as a function of the baseline proximal pressure, the baseline distal pressure, the absolute proximal pressure, and the absolute distal pressure.

2. The system of claim 1, wherein the pump comprises a pumping cassette, the pump chassis latching the pumping cassette in a predetermined position within the pump chassis before the controller begins monitoring the proximal pressure and the distal pressure.

3. The system of claim 2, wherein latching the pumping cassette in the pump chassis applies a preload force from the elastomeric membrane directed against the proximal pressure sensor and against the distal pressure sensor through their respective members, said preload force tending to stabilize a zero proximal pressure signal and a zero distal pressure signal.

4. The system of claim 2, wherein the proximal pressure sensor and the distal pressure sensor each comprise:

(a) a beam having an end rigidly connected to the pump chassis and a free end that flexes in response to a force applied by the member; and

(b) a strain gauge mounted on the beam, said strain gauge responding to a flexure of the beam by producing an output signal indicative of one of the proximal and the distal pressures.

5. The system of claim 4, wherein the member of each of the proximal and distal pressure sensors comprises an elongate rod that is movable along a longitudinal axis of the rod within an orifice that is disposed in the pump chassis, in response to a force exerted by the fluid within the pumping cassette against the elastomeric membrane, said force being a function of a fluid pressure.

6. The system of claim 5, wherein each rod is impregnated with at least one material selected to substantially reduce friction between the rod and the orifice in the pump chassis through which the rod moves.

7. The system of claim 5, where each beam includes a knob mounted on the free end thereof, adjacent to an end of the rod, at least one of the end of the rod and an end of the knob that contacts the end of the rod including a surface having a curvature selected to isolate the beam from any forces by the rod that are not directed generally in parallel with the longitudinal axis of the rod.

8. The system of claim 7, wherein each knob is fabricated of a material selected because of its low coefficient of friction, to minimize an effect of forces applied to the knob by the rod that are not substantially normal to the beam.

9. The system of claim 7, wherein the rod of the distal pressure sensor contacts a flow stop disposed on the pumping cassette, the flow stop being disposed adjacent to and in contact with a portion of the elastomeric membrane within the pumping cassette.

10. The system of claim 9, wherein the flow stop is pivotally mounted on the pumping cassette to pivot between an open position in which the flow stop permits a flow of fluid through the pumping cassette and transmits a force from the elastomeric membrane to the rod of the distal pressure sensor that corresponds to the distal pressure, and a closed position in which the flow stop interrupts a free flow of the fluid through the pumping cassette, the rod of the distal pressure sensor automatically moving the flow stop to the open position when the pumping cassette is latched into the chassis.

11. The system of claim 1, wherein the controller comprises:

(a) a processor;

(b) user interface that permits entry of data by a user;

(c) a display for displaying prompts and information to a user; and

(d) a memory that is coupled to the processor, the memory storing a plurality machine instructions that cause the processor to perform a plurality of logical steps when the machine instructions are executed by the processor, said logical steps including;

(i) enabling calibration of the proximal pressure sensor and the distal pressure sensor before the pump is initially placed into operation to pump the fluid, said calibration storing a proximal offset, a distal offset, and calibration threshold values for the proximal pressure sensor and the distal pressure sensor in the memory;

(ii) when the pump is placed into operation to pump the fluid, sampling the proximal pressure signal produced by the proximal pressure sensor and the distal pressure signal produced by the distal pressure sensor to determine the baseline proximal pressure and the baseline distal pressure, respectively, using the proximal offset and the distal offset and the calibration threshold values; and

(iii) producing an occlusion alarm on the display if samples of the proximal pressure signal or the distal pressure signal indicate that the impediment to the fluid flow has occurred.

12. The system of claim 11, wherein the controller further includes an analog-to-digital converter that converts the proximal pressure signal to a corresponding digital value and the distal pressure signal to a corresponding digital value.

13. A method for detecting an impediment to fluid flow through an intravenous line in which is disposed a pump for infusing a medicinal fluid into a patient, comprising the steps of:

(a) sensing a fluid pressure in the pump, producing a fluid pressure signal;

(b) sampling the fluid pressure signal a plurality of time, when the pump is at a predefined point in a pumping cycle, producing samples;

(c) determining a baseline pressure;

(d) detecting that an impediment to fluid flow has occurred as a function of the baseline pressure and a threshold value; and

(e) providing an alarm to alert a user if the impediment to fluid flow is detected.

14. The method of claim 13, further comprising the step of providing a pressure calibration of a pressure sensor used to sense the fluid pressure in the pump before the pump is made available for use infusing the medicinal fluid into the patient.

15. The method of claim 13, wherein the step of sampling further comprises the steps of:

(a) determining if the pump is energized; and

if so,

(b) determining if the pump is pumping the fluid; and

if so,

(c) enabling samples to be taken to determine the baseline pressure.

16. The method of claim 13, wherein the step of determining the baseline pressure comprises the steps of:

(a) determining if a difference between the successive samples is within a predetermined limit; and

if true

(b) determining the average of the successive samples for use as the baseline pressure;

but if false

(c) discarding a last of the successive samples;

(d) taking another sample, which becomes the last sample; and

(e) repeating the steps of this claim until the average for use as the baseline pressure is determined.

17. The method of claim 13, wherein the step of determining the baseline pressure comprises the steps of:

(a) determining a maximum value of the samples taken since the pump began to operate, while excluding any sample that differs by more than a predefined limit from a previous sample; and

(b) limiting the baseline pressure to a value that is the greater of a predefined function of the maximum value, and a specified pressure value.

18. The method of claim 13, wherein the step of determining the baseline pressure comprises the steps of:

(a) determining a minimum value of the samples taken since the pump began to operate, while excluding any sample that differs by more than a predefined limit from a previous sample; and

(b) limiting the baseline pressure to a value that is the lesser of a predefined function of the minimum value, and a specified pressure value.

19. The method of claim 13, wherein the step of determining the baseline pressure further comprises the step of eliminating any samples taken while the fluid pressure signal indicates that the pump is not operating, so that said samples are not used to determine the baseline pressure.

20. The method of claim 13, further comprising the steps of determining an operating speed of the pump and determining a rate for sampling the pressure signal as a function of said operating speed.

21. The method of claim 13, further comprising the step of detecting that an impediment to fluid flow has occurred as a function of an absolute pressure that is independent of the baseline pressure.

22. The method of claim 21, wherein the impediment to fluid flow is detected if a difference between the absolute pressure and a predetermined value is exceeded.

23. The method of claim 13, wherein the fluid pressure signal is indicative of one of a proximal pressure and a distal pressure in the intravenous line.

24. An occlusion detector disposed in a pump that infuses a medicinal fluid into a patient through an intravenous line, for determining if an impediment to fluid flow through the intravenous line has occurred, comprising:

(a) a beam that is cantilever mounted to the pump, so that a free end of the beam is able to flex in response to a force applied to the free end of the beam;

(b) a strain gauge mounted on the beam so as to sense a deflection of the beam;

(c) an elongate rod disposed within an orifice formed within the pump and movable in a direction aligned with a longitudinal axis of the rod, one end of the rod contacting the free end of the beam, an opposite end of the rod having a force corresponding to a fluid pressure within the intravenous line applied thereto, in the direction of the longitudinal axis of the rod, said force causing the beam to deflect and thus causing the strain gauge to produce a signal indicative of the fluid pressure;

(d) an alarm indicative of an impediment to fluid flow through the intravenous line; and

(e) a controller coupled to the strain gauge to receive the signal, said controller sampling the signal to produce samples and to determine a baseline pressure while the pump is operating, and as a function of the baseline pressure, determining a relative pressure, said controller detecting an impediment to the fluid flow through the intravenous line as a function of the relative pressure and causing the alarm to be activated to alert a user of the impediment to the fluid flow.

25. The occlusion detector of claim 24, wherein the signal is indicative of one of a distal pressure and a proximal pressure in the intravenous line.

26. The occlusion detector of claim 24, wherein the rod is fabricated of a material selected for its low coefficient of friction, to minimize friction between the rod and sides of the orifice.

27. The occlusion detector of claim 24, wherein the free end of the beam includes a knob disposed adjacent to and in contact with the end of the rod, at least one of the end of the rod and a surface of the knob in contact with the end of the rod being rounded to minimize application of force by the rod on the beam that is not aligned with the longitudinal axis of the rod.

28. The occlusion detector of claim 24, wherein the baseline pressure is:

(a) reset each time the pump is energized; and

(b) determined by averaging a plurality of samples that do not differ from each other by more than a predetermined amount.

29. The occlusion detector of claim 25, wherein the pump is adapted to drive a pumping cassette that includes an elastomeric membrane that is in contact with the medicinal fluid, said rod being adapted to receive the force from the elastomeric membrane in response to the pressure of the medicinal fluid flowing through the intravenous line.

30. The occlusion detector of claim 28, wherein the baseline pressure is limited to the greater of a predefined function of a maximum sample, and a predetermined value.

31. The occlusion detector of claim 28, wherein the baseline pressure is limited to the lesser of a predefined function of a minimum sample, and a predetermined value.

32. The occlusion detector of claim 28, wherein the controller detects an impediment to the fluid flow as a function of an absolute pressure derived from the samples and independent of the baseline pressure.

33. A system for detecting an impediment to a fluid flow through an intravenous line, comprising:

(a) a pump chassis;

(b) a pump in fluid communication with the intravenous line and mountable within the pump chassis to receive a driving force, said pump including a proximal port, a distal port, an elastomeric membrane overlying a fluid path through the fluid pump adjacent the proximal port and distal port, and a flow stop that is in contact with the elastomeric membrane adjacent to the distal port, said flow stop being movable between a stop position in which it applies a force to the elastomeric membrane that closes off fluid flow through the pump and a sensing position in which it transmits force produced by a distal pressure within the pump and thus, indicative of the distal pressure;

(c) a proximal pressure sensor mounted on the pump chassis and including a member that is coupled to the elastomeric membrane adjacent to the proximal port of the pump and responsive to a deflection and force exerted by the elastomeric membrane due to a proximal fluid pressure within the pump, producing a proximal pressure signal indicative thereof;

(d) a distal pressure sensor mounted on the pump chassis and coupled to the flow stop to respond to the force transmitted by the flow stop from the elastomeric membrane, producing a distal pressure signal indicative thereof; and

(e) a controller that is electrically coupled to the proximal pressure sensor and the distal pressure sensor to receive the proximal and distal pressure signals, said controller employing the proximal pressure signal to determine a proximal fluid pressure, and employing the distal pressure signal to determine a distal fluid pressure, and determining whether an impediment to fluid flow through the intravenous line has occurred as a function of the proximal fluid pressure, and of the distal fluid pressure.