Constant pressure blood mixture delivery system and method

• US 5,645,531 A
• Filed: 03/01/1994
• Issued: 07/08/1997
• Est. Priority Date: 05/26/1993
• Status: Expired due to Term

• Current Assignee: QMI Medical, Inc. (Atrion Corporation)
• Original Assignee: Quest Medical Incorporated (Atrion Corporation)
• Inventors: Thompson, Thomas C., Jones, Kenneth A., Abbott, Martyn
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/204,530
• Time in Patent Office: 1,225 Days
• Field of Search: 604/4, 604/27-29, 604/65-67, 604/131, 604/151, 604/153, 604/48, 128/DIG. 3, 128/DIG. 12
• US Class Current: 604/67
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: Y10S 128/03 Heart-lung

Abstract

A system and method for blood mixture fluid delivery to a patient includes fluid delivery conduits connected to the patient for delivering blood mixture fluid, a pump for controlled pumping of blood mixture fluid through the conduits to the patient, and an automatic control mechanism operatively connected to the pump for controlling the pump so that the blood mixture fluid is continuously delivered to the patient at a defined constant pressure.

Claims

1. A method for establishing constant pressure blood mixture fluid delivery to a patient comprising the steps of:

(a) connecting a fluid delivery tube between the patient and an adjustable rate pump of a type for pumping blood mixture fluid at an adjustable flow rate;

(b) increasing the rate of pumping of fluid to the patient through the tube;

(c) measuring pressure in the fluid delivery tube while increasing the flow rate there through; and

(d) upon measuring a desired pressure, simultaneously disengaging a manual flow rate adjustment mechanism and engaging an automatic control mechanism by which the flow rate in said fluid delivery tube is automatically adjusted to maintain said desired pressure.

2. A system for blood mixture fluid delivery to a vascular system of a patient comprising:

(a) a fluid delivery conduit connectable to said vascular system of the patient for delivering a blood mixture fluid;

(b) a pump interconnected to said fluid delivery conduit for controlled pumping of said blood mixture fluid through said conduit to said vascular system of the patient; and

(c) a control mechanism operatively connected to said pump for controlling a rate at which fluid is pumped from said pump so that said blood mixture fluid is delivered to said vascular system of the patient at a defined and maintained constant pressure.

3. A system for blood mixture fluid delivery as in claim 2 wherein said fluid delivery conduit is an arterial conduit for coupling said delivery system to said patient'"'"'s arterial blood vessel system.

4. A system for blood mixture fluid delivery as in claim 2 wherein said fluid delivery conduit is a venous conduit for coupling said delivery system to said patient'"'"'s venous blood vessel system.

5. A system for blood mixture fluid delivery as in claim 2 wherein;

(a) said pump has a variable flow rate within a predetermined range of flow rates; and

(b) wherein said control mechanism, for controlling said rate at which fluid is pumped from said pump, automatically controls and maintains fluid delivery at said defined constant pressure and includes;

i. a pressure sensor operatively connected with said fluid delivery conduit for detecting a blood mixture fluid delivery pressure to said vascular system of the patient and for producing a representative signal of said detected pressure; and

ii. control circuitry for receiving said representative pressure signal and for automatically increasing said variable flow rate upon detecting a pressure below said defined constant pressure, for automatically decreasing said variable flow rate upon detecting a pressure above said defined constant pressure and for automatically holding said flow rate constant upon detecting a pressure equal to said defined constant pressure so that said blood mixture fluid is delivered to said vascular system of the patient at said defined constant pressure.

6. A system for blood mixture fluid delivery as in claim 2 further comprising:

(a) a fluid path in said system which includes said fluid delivery conduit and said pump;

(b) a pressure display, coupled to said control mechanism, by which said defined and maintained constant delivery pressure is displayed; and

(c) a flow rate display, coupled to said control mechanism, which displays an actual fluid flow rate measured along said fluid path in said system, such actual fluid flow rate being proportional to said defined constant pressure.

7. A system for blood mixture fluid delivery as in claim 6 further comprising:

(a) a flow rate adjustment device coupled to said control mechanism; and

(b) a switch, coupled to said control mechanism, for changing between a flow rate control mode and a constant pressure control mode whereby,

(i) in said flow rate control mode, said actual fluid flow rate is changed by manually adjusting said flow rate adjustment device, and

(ii) in said constant pressure control mode, by which said flow rate adjustment device is deactivated, said control mechanism is enabled to automatically maintain a fluid delivery pressure substantially consistent with said defined constant pressure through automatic adjustment of the actual fluid flow rate.

8. A system for blood mixture fluid delivery as in claim 7 further comprising:

(a) means, coupled to said control mechanism, for defining an upper pressure limit; and

(b) means, coupled to said control mechanism, for defining a lower pressure limit.

9. A system for blood mixture fluid delivery as in claim 8 further comprising means, coupled to said control mechanism, for defining an upper flow rate limit and for defining a lower flow rate limit based upon said upper pressure limit and said lower pressure limit, respectively, said actual fluid flow rate and an actual fluid pressure, such actual flow rate and actual fluid pressure being determined upon activation of said constant pressure control mode.

10. A system for blood mixture fluid delivery as in claim 9 further comprising:

(a) a monitoring means within said fluid path;

(b) a first alarm, being coupled to said monitoring means within said fluid path, to operatively monitor said actual fluid flow rate, to provide a first signal if said actual fluid flow rate exceeds said upper flow rate limit or falls below said lower flow rate limit;

(c) a second alarm, being coupled to said monitoring means within said fluid path, to monitor said actual fluid flow rate, to provide a second signal if said actual fluid flow rate exceeds said upper flow rate limit for a first predetermined period of time or said actual flow rate falls below said lower flow rate limit for a second predetermined period of time;

(d) an automatic shut-off switch, coupled to said control mechanism, by which said pump will be deactivated if said actual fluid flow rate exceeds said upper flow rate limit for a third predetermined period of time after said second signal has occurred or if said actual fluid flow rate falls below said lower flow rate limit for a fourth predetermined period of time after said second alarm has occurred; and

(e) an operator override switch, coupled to said control mechanism, by which said at least one of said first and second signals can be manually overridden by an operator to discontinue at least one of the signals and continue operation of the pump even when said upper and lower flow rate limits are exceeded.

11. A system for blood mixture fluid delivery as in claim 8 further comprising:

(a) computer processing circuitry, operatively connected to said control mechanism, for automatically calculating upper and lower flow rate limits based upon upper and lower pressure limits set with said means for setting upper and lower pressure limits; and

(b) means, coupled to said computer processing circuitry, for automatically setting said upper and lower flow rate limits based upon said calculated upper and lower flow rate limits upon actuation of said constant pressure control mode.

12. A system for blood mixture fluid delivery as in claim 2 further comprising:

(a) means for setting upper pressure and lower pressure limits, said means operatively connected to said system for blood mixture fluid delivery; and

(b) means, coupled to said control mechanism, for automatically establishing an upper flow rate limit and a lower flow rate limit based upon set upper pressure and lower pressure limits.

13. A system for blood mixture fluid delivery as in claim 12 further comprising:

(a) a fluid path through said system;

(b) a monitoring means for monitoring actual pressure within said fluid path;

(c) a first alarm, being coupled to said monitoring means within said fluid path through said system to operatively monitor an actual fluid flow rate, to provide a visual signal if said actual fluid flow rate exceeds said upper flow rate limit or falls below said lower flow rate limit;

(d) a second alarm, being coupled to said monitoring means within said fluid path, to monitor said actual flow rate, to provide an audible signal if said actual fluid flow rate exceeds said upper flow rate limit for a first predetermined period of time or said actual fluid flow rate falls below said lower flow rate limit for a second predetermined period of time;

(e) an automatic shut-off switch, coupled to said control mechanism, by which said pump will be deactivated if said actual fluid flow rate exceeds said upper flow rate limit for a third predetermined period of time after said audible signal has occurred or if said actual fluid flow rate falls below said lower flow rate limit for a fourth predetermined period of time after said audible signal has occurred; and

(f) an operator override switch, coupled to said control mechanism, by which said automatic shut-off switch and at least one of said visual and audible alarms can be manually overridden by an operator to discontinue at least one of the signals to continue operation of the pump even when said upper and lower flow rate limits are exceeded.

14. A system for blood mixture fluid delivery as in claim 12 further comprising:

(a) a fluid path through said system;

(b) a monitoring means for monitoring actual pressure within said fluid path;

(c) a first alarm, being coupled to said monitoring means within said fluid path through said system to operatively monitor an actual fluid pressure within said fluid path, to provide a visual signal if said actual fluid pressure exceeds said upper pressure limit or falls below said lower pressure limit;

(d) a second alarm, being coupled to said monitoring means within said fluid path to monitor said actual fluid pressure, to provide an audible signal when said actual fluid pressure exceeds said upper pressure limit for a first predetermined period of time or said actual fluid pressure falls below said lower pressure limit for a second predetermined period of time; and

(e) an operator override switch, coupled to said control mechanism, by which at least one of said visual and said audible signals can be manually overridden by an operator to discontinue at least one of the alarms to continue operation of the pump even when said upper and lower pressure limits are exceeded.

15. A system for blood mixture fluid delivery as in claim 2 wherein said system is a cardioplegia delivery system.

16. A system for blood mixture fluid delivery as in claim 2 wherein said system is a limb reperfusion system.

17. A system for blood mixture fluid delivery as in claim 2 wherein said system is a cerebral perfusion system.

18. A system for blood mixture fluid delivery to a patient comprising:

(a) fluid delivery conduits connectable to said patient for delivering a blood mixture fluid wherein said fluid delivery conduits are operatively positioned within said patient'"'"'s arterial vascular system and said patient'"'"'s venous vascular system, and operatively connected to said system for blood mixture fluid delivery for selectable delivery to either said arterial system or to said venous system of said patient;

(b) a pump interconnected to said fluid delivery conduits for controlled pumping of said blood mixture fluid through said conduits to the patient; and

(c) a control mechanism operatively connected to said pump for controlling said pump so that said blood mixture fluid is delivered to the patient at a defined constant pressure.

19. A system for blood mixture fluid delivery to a patient comprising:

(a) a fluid delivery conduit connectable to said patient for delivering a blood mixture fluid;

(b) a pump, having an adjustably variable flow rate and interconnected to said fluid delivery conduit, for controlled pumping of said blood mixture fluid through said conduit to the patient; and

(c) a control mechanism operatively connected to said pump for controlling said pump so that said blood mixture fluid is delivered to the patient at a defined constant pressure, said control mechanism including;

i. means for manually adjusting a variable flow rate;

ii. means for automatically controlling said variable flow rate to maintain said defined constant pressure; and

iii. means for selecting between said manual flow rate control and said automatic flow rate control for maintaining said defined constant pressure.

20. A system for blood mixture fluid delivery as in claim 19 wherein said means for selecting between said manual and said automatic control comprises a mode selection switch having (i) a first position, in which said means for manually adjusting said variable flow rate is activated, and (ii) a second position, in which said means for automatically controlling said variable flow rate to maintain said defined constant pressure is activated.

21. A system for blood mixture fluid delivery to a vascular system of a patient at a constant pressure comprising:

(a) means for selecting a defined constant pressure;

(b) pump means for delivering a blood mixture fluid under pressure to said vascular system of the patient;

(c) a monitor for measuring pressure of said blood mixture fluid delivered to said vascular system of the patient and for providing a signal representative of said measured pressure; and

(d) control means, coupled between said means for selecting a defined constant pressure, said pump means and said monitor means, responsive to said signal representative of said measured pressure for controlling the rate at which fluid is pumped by said pump means so that said blood mixture fluid is delivered and maintained at said defined constant pressure.

22. A system for blood mixture fluid delivery to a vascular system of a patient at a constant pressure, wherein said delivery system comprises:

(a) means for controlling a variable blood mixture fluid flow rate in said delivery system;

(b) a control mechanism operatively associated with said means for controlling a variable blood mixture fluid flow rate for maintaining said constant pressure by controlling said variable blood mixture fluid flow rate;

(c) means, coupled to said control mechanism, to allow initial adjustment of said variable blood mixture fluid flow rate until a defined fluid delivery pressure is achieved, such defined fluid delivery pressure corresponding to a defined constant pressure; and

(d) means, coupled to said control mechanism, to allow changing an operation mode of the delivery system to a constant pressure mode whereby in said constant pressure mode said variable blood mixture fluid flow rate is automatically varied so that said fluid delivery pressure is constantly maintained at said defined constant pressure.

23. A system for blood mixture fluid delivery to a patient comprising:

(a) fluid delivery conduit, operatively positioned within said patient at a delivery situs, for delivering a blood mixture fluid to said delivery situs;

(b) a pump, coupled to said fluid delivery conduit, for producing a pressurized flow of said blood mixture fluid through said conduit to the patient;

(c) a control mechanism, coupled to said pump, having a first manual flow rate control mode and having a second automatic constant pressure control mode operatively connected to said pump; and

(d) means, coupled to said control mechanism, for selectably choosing said manual flow rate control mode or said automatic constant pressure control mode.

24. A system for blood mixture fluid delivery as in claim 23 further comprising means, coupled to said control mechanism, for providing a measurement of a fluid flow rate in said system at the time of selectably choosing said automatic constant pressure control mode and for automatically setting high and low flow rate limits using an algorithm based upon a measurement of a fluid flow rate in said system at the time of selectably choosing said automatic constant pressure control mode.

25. A system for blood mixture fluid delivery as in claim 23 further comprising means, coupled to said control mechanism, for manually selecting high and low flow rate limits for said automatic constant pressure control mode.

26. A system for blood mixture fluid delivery as in claim 23 further comprising a display panel, coupled to said control mechanism, having:

(a) a means for selecting between said manual flow rate control mode and said automatic constant pressure control mode;

(b) a first flow rate measurement and visual display device for measuring and displaying a measured fluid flow rate; and

(c) a second pressure measurement and visual display device for measuring and displaying a measured fluid pressure.

27. A system for blood mixture fluid delivery as in claim 26 further comprises:

(a) an upper limit display area on said display panel;

(b) a lower limit display area on said display panel;

(c) means for defining an upper pressure limit to be displayed in said upper limit display area; and

(d) means for defining a lower pressure limit for display in said lower limit display area.

28. A system for blood mixture fluid delivery as in claim 27 further comprises:

means operatively connected with said means for selecting between said automatic manual control mode and said automatic constant control mode for automatically defining upper and lower flow rate limits based upon displayed upper and lower pressure limits and for automatically replacing said upper and lower pressure limits with said automatically defined upper and lower flow rate limits for display in said upper and lower limit display areas.

29. A system for blood mixture fluid delivery as in claim 28 wherein,

(a) said display panel further includes,

(i) a first display area for visually designating said upper and said lower display areas for pressure limit display;

(ii) a second display area for visually designating said upper and said lower limit display areas for flow rate limit display; and

(b) said control means further includes means for blanking out said pressure limit designation upon activation of said automatic constant pressure control mode and eliminating said pressure limit display, or alternatively for blanking said flow rate limit designation display and for elimination of said flow rate limit display upon deactivation of said automatic constant pressure control mode and reactivation of said manual flow rate adjustment mode.