Computer-control medical care system

• US 4,370,983 A
• Filed: 04/30/1979
• Issued: 02/01/1983
• Est. Priority Date: 01/20/1971
• Status: Expired due to Term

• Current Assignee: Eric S. Lichtenstein
• Original Assignee: Eric S. Lichtenstein
• Inventors: Lichtenstein, Eric S.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/034,539
• Time in Patent Office: 1,373 Days
• Field of Search: 128/630, 128/214 E, 128/214 F, 210/331 R, 210/331 A, 210/331 B, 210/321.2, 364/415-417
• US Class Current: 600/301
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3417 using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/3431 upstream of the filter
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3468 using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3482 by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3639 : Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 : Pressure isolators
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 1/3679 : by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0241 : Anaesthetics; Analgesics
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/331 : used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 3/0201 : Cassettes therefor
• CPC Class Codes: A61M 3/0202 : with electronic control means or interfaces
• CPC Class Codes: A61M 3/0216 : Pressure
• CPC Class Codes: A61M 3/022 : Volume; Flow rate
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/38 : Blood oxygenation
• CPC Class Codes: A61M 60/441 : generated by an electromotor
• CPC Class Codes: A61M 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/851 : Valves
• CPC Class Codes: F04B 43/06 : Pumps having fluid drive
• CPC Class Codes: Y10S 128/13 : Infusion monitoring
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

Abstract

A computer-controlled medical care system for use in the treatment and diagnosis of patients provides for either automatic or manual control of a wide variety of medical procedures including diagnostic procedures. The system accepts modular vessel structures, each type of structure being adapted for carrying out a specific procedure and matching programs for carrying out the specific procedures. A microcomputer accepts a program which may be designed to fit the needs of a specific patient and which must match the modular vessel structure. The microcomputer monitors the progress of the process and the physiologic status of the patient and provides for the taking of appropriate steps should difficulties be encountered in carrying out the procedure. The system can also be programmed to analyze a fluid taken from an individual, to treat the fluid and return same to the individual and to schedule the infusion of appropriate medications.

Embodiments of the system provide for carrying out only a limited group of procedures where a full-range system is undesirable either because unnecessary or uneconomic.

Modular vessel structures are keyed to specific programs, thereby preventing operator errors and increasing the reliability of the system.

Claims

1. A computer-controlled medical care system suitable for carrying out any of a plurality of selected medical procedures in response to any of a plurality of selected programs, the term "medical procedures" being taken as inclusive of diagnostic and therapeutic procedures comprising:

computer means for receiving any of said plurality of programs, each of said programs being associated with a specific medical procedure;

at least one modular vessel structure, each modular vessel structure hereinafter termed "module";

support means for holding at least one said module, said module including first duct means for connecting with an individual and being arranged and constructed for cooperation with said support means for carrying out a selected procedure, said module including procedure-indicating means for indicating the specific procedure for which said module is designed;

and procedure-sensing and signalling means for sensing said specific procedure when said module is held in said support means for communicating the nature of said specific procedure to said computer means, said computer means being arranged and constructed for comparing said specific procedure with a selected program and for indicating whether said specific procedure and selected program correspond.

2. The computer-controlled medical care system as claimed in claim 1 further comprising

fluid transfer means for transferring fluid through said first duct means at a rate corresponding to said selected program;

and

first indicator means connected with said computer means for indicating the status of said selected procedure relative to the selected program and indicating any adjustment necessary for establishing correspondence therebetween.

3. The computer-controlled medical care system, as defined in claim 2, further comprising first pressure sensor means for measuring the pressure in said module and communicating the value of said pressure to said computer means, said computer means being arranged and constructed for controlling said fluid transfer means for making adjustment in said pressure in accordance with said selected program.

4. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said support means is arranged and constructed for receiving said module for use in withdrawal of a fluid from an individual.

5. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said support means is arranged and constructed for receiving said module for use in infusion of a fluid to a patient.

6. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said support means is arranged and constructed for receiving said module for use in extracorporeal circulation and treatment of said fluid.

7. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said transfer means is arranged and constructed for taking fluid from an individual and for transferring fluid from said module to a second individual.

8. The computer-controlled medical care system, as defined in claim 2, wherein said support means is arranged and constructed for receiving said module for use in transferring a fluid to an individual and in adding a medication to said fluid.

9. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said support means is arranged and constructed for receiving said module for use in withdrawing a fluid from said individual, analyzing said fluid for a specific component and signalling the results of said analysis to said computer means.

10. The computer-controlled medical care system, as defined in claim 9, wherein said support means is arranged and constructed for receiving said module for supplying a second fluid to said individual, said computer means being arranged and constructed for indicating the appropriate adjustment in the rate of supply of said second fluid on the basis of said analysis and said selected program.

11. The computer-controlled medical care system, as defined in claim 3, wherein said computer means is arranged and constructed for transferring said fluid between said module and said individual and for determining the pressure of said fluid within said individual and for indicating said pressure.

12. The computer-controlled medical care system, as defined in claims 2 or 3, further comprising means for sensing a parameter indicative of the physiologic status of said individual and wherein said computer means is arranged and constructed for indicating appropriate adjustment in the rate of transfer of said fluid in accordance with said selected program.

13. The computer-controlled medical care system, as defined in claims 2 or 3, further comprising means for sensing a parameter indicative of the physiologic status of said idividual and for signalling the value of said parameter to said computer means, and wherein said support means is arranged and constructed for receiving said module for adjusting the rate of transfer of said fluid between said individual and said module, said computer means being constructed and arranged for indicating appropriate adjustment in the rate of supply of a medication on the basis of said parameter and said selected program.

14. The computer-controlled medical care system, as defined in claim 13, wherein said sensed parameter is an inherent electrical activity of the individual.

15. The computer-controlled medical care system, as defined in claim 14, wherein said sensed inherent electrical activity is that of the individual'"'"'s heart as sensed by an ECG and said medication is an arrhythmia suppressant.

16. The computer-controlled medical care system, as defined in claim 13, wherein said sensed parameter is an impedance change in the individual.

17. The computer-controlled medical care system, as defined in claim 13, wherein said paramter-sensing means is an electrode, the term "electrode" being taken to include both an implanted and an external electrode for determining electrical potential, voltage difference, electrical resistance, specific ions and gas partial pressure.

18. The computer-controlled medical care system, as defined in claim 2 or 3, wherein said computer means is arranged and constructed for controlling the volume and rate of fluid infusion to said individual.

19. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said transfer means is arranged and constructed for taking fluid from an individual, and returning said fluid to said individual, said system further comprising treatment means for treating said fluid prior to returning same to said individual.

20. The computer-controlled medical care system, as defined in claim 19, wherein said support means is arranged and constructed for receiving said module comprising debubbling means for removing bubbles from said fluid prior to infusion of same.

21. The computer-controlled medical care system, as defined in claim 20, wherein said module further comprises vent means for venting said debubbling means.

22. The computer-controlled medical care system, as defined in claim 21, further comprising level sensor means for detecting the level of fluid in said debubbling means.

23. The computer-controlled medical care system, as defined in claim 2, further comprising first pressure sensor means for measuring the pressure in said first duct means and communicating the value of said pressure to said computer means, and wherein said computer means is arranged and constructed for indicating appropriate adjustment of said medical procedure on the basis of said communicated pressure value and said selected program.

24. The computer-controlled medical care system, as defined in claim 2, wherein said support means is arranged and constructed for receiving said module comprising a plurality of chambers for holding therein a plurality of fluids, said chambers being selectively connectable with said transfer means for programmed transfer of at least one of said fluids and said computer means being arranged and constructed for indicating appropriate adjustment of the rate of transfer of said fluid.

25. The computer-controlled medical care system, as defined in claims 2 or 3, wherein said support means is arranged and constructed for receiving at least one said module including second duct means, said first and second duct means being connectable with an individual for respectively taking and infusing a fluid from and to said individual, and further comprising second sensor means for sensing the rate of transfer of fluid in said second duct means and for communicating said rate in said second duct means to said computer means.

26. The computer-controlled medical care system, as defined in claim 25, wherein said computer means is arranged and constructed for determining the difference between said rates of transfer and further comprising second indicator means connected with said computer means for indicating said difference.

27. The computer-controlled medical care system, as defined in claim 26, wherein one of said transfer rates is zero.

28. The computer-controlled medical care system, as defined in claim 26, further comprising rapid integrating and indicating means associated with said computer means for integrating said difference with time, and for indicating said integrated difference, thereby providing essentially concurrent information as to accumulation or deficit of fluid.

29. The computer-controlled medical care system, as defined in claim 28, wherein said computer means is arranged and constructed for comparing said integrated difference with said selected program and for indicating appropriate adjustment for establishing correspondence between said integrated difference and said program.

30. The computer-controlled medical care system, as defined in claim 24 further comprising integrator means associated with said computer means for integrating the flow rate through said module caused by said fluid transfer means and for thereby providing information as to volume of fluid transferred through said module as a function of time.

31. The computer-controlled medical care system, as defined in claim 2, wherein said support means is arranged and constructed for receiving said module having therein first chamber means, said first duct means being connected with said first chamber means and connectable with said individual for transfer of fluid between said first chamber means and said individual.

32. The computer-controlled medical care system, as defined in claim 31, wherein said first duct means is connected with said first chamber means for transfer of said fluid to said individual and further comprising second chamber means and second duct means connecting said second chamber means with said fluid duct means for mixing fluids from said first and second chamber means, said first transfer means being arranged and constructed for transfer of fluid through said first duct means at a controlled rate, and further comprising second transfer means for transferring fluid through said second duct means at a rate corresponding to said selected program.

33. The computer-controlled medical care system, as defined in claim 31, further comprising parameter-sensing means for sensing at least one parameter indicative of the physiologic status of said individual and for signalling the value of said parameter to said computer means and wherein said support means is arranged and constructed for receiving said module for supplying to said individual fluid from at least one of said chamber, said computer means being arranged and constructed for indicating appropriate adjustment in the rate of supply of said fluid on the basis of and sensed parameter and said selected program.

34. The computer-controlled medical care system, as defined in claim 33, wherein said parameter-sensing means is arranged and constructed for sensing at least one of the parameters:

cardiovascular system pressures;

pulse rate;

heart rhythm;

volume of cardiac output;

urine output;

tissue perfusion;

body temperature;

respiration rate;

blood oxygen content;

spinal fluid pressure;

partial pressure of gas dissolved in body fluid;

or

chemical composition of body fluid,

whereby said system is suitable for monitoring and treatment of an individual suffering or subject to physiological aberration.

35. The computer-controlled medical care system, as defined in any of claims 2, 3, 24, 25, 32, 33, or 34, wherein said indicator means comprises controller means for effecting said adjustment automatically.

36. The computer-controlled medical care system, as defined in claim 2, wherein said support means includes a contoured surface hereinafter termed interface means for holding at least portions of said module in a fixed configuration, at least a portion of said module being flexible.

37. The computer-controlled medical care system, as defined in claim 36, wherein said fluid transfer means comprises pump means for cooperating with said flexible portion of said module in transferring fluid therethrough.

38. The computer-controlled medical care system, as defined in claim 36, wherein said support means includes compression means for at least partially closing a lumen of said module held in said interface.

39. The computer-controlled medical care system, as defined in claim 2, wherein said computer means is arranged and constructed for connection to a program indicating means incorporated in said module for indicating at least the procedure for which said module is designed.

63. The computer-controlled medical care system as defined in claim 12, wherein said indicating means comprises controller means for effecting said adjustment automatically.

64. The computer-controlled medical care system as defined in claim 13, wherein said indicating means comprises controller means for effecting said adjustment automatically.

40. Apparatus for cooperating with any of a plurality of types of modular vessel structures, each type of modular vessel structure hereinafter termed "modules", in carrying out any of a plurality of selected medical procedures on an individual, the term "medical procedure" being taken as inclusive of diagnostic and therapeutic procedures, said apparatus comprising:

computer means programmable for monitoring each selected procedure and determining any necessary adjustment in said procedure;

a first region for retaining a first said module in a fixed pattern, said module including first tubing means;

first variable-rate pump means in said first region for receiving and cooperating with said first tubing means and transferring fluid therethrough;

first sensor means for sensing the value of a first variable of said fluid within said first module relating to a selected one of said medical procedures and indicative of the progress of a first said selected procedure and for signalling said value to said computer means;

first indicator means connected with said computer means for indicating appropriate adjustment in said first selected procedure;

a second region for retaining a second said module in a fixed pattern, said second module including a second and third tubing means;

second variable-rate means in said region for transferring fluid through said second and third tubing means;

second sensor means for sensing the value of a second variable of said fluid within said second module relating to a second selected medical procedure and indicative of the progress of said second selected procedure and for signalling said value to said computer means, said computer means being arranged and constructed for evaluating said signalled values and determining any necessary adjustment in said second procedure on the basis of said second variable; and

second indicator means connected with said computer means for indicating said necessary adjustment in said second procedure.

41. The apparatus as defined in claim 40, wherein at least one of said sensor means is a pressure sensor.

42. The apparatus of claim 40, wherein at least one of said sensor means is a flow-rate sensor.

43. The apparatus of claim 40, wherein at least one of said sensor means is the combination of an ultrasonic generator and detector.

44. The apparatus of claim 40, wherein at least one of said sensor means is a conductivity sensor.

45. The apparatus of claim 40, further comprising sensor means for sensing impedance change in fluid within said module.

46. The apparatus of claim 40, wherein at least one of said sensor means is a light sensor.

47. The apparatus of claim 40, further comprising physiologic status sensor means adaptable to be connected to said individual and with said computer means for monitoring at least one variable indicative of the individual'"'"'s physiologic condition, said computer means being arranged and constructed for indicating by said indicator means any necessary adjustment in a selected procedure in progress.

48. The apparatus of claim 47, wherein said physiologic status sensor means is a pressure-sensor for determining at least one pressure in said individual.

49. The apparatus of claim 47, wherein said physiologic status sensor means is a plethysmograph sensor.

50. The apparatus of claim 49, further comprising valve means for controlling the rate of flow of fluid through said tubing means.

51. The apparatus of claim 50, wherein said valve means comprises compression means selectively urgeable against said module for at least partially closing a lumen thereof.

52. The apparatus of claim 40, further comprising means for detecting microemboli in fluid in one of said vessel structures.

53. The apparatus of claim 40, further comprising a plurality of valve means for cooperating with one of said vessel structures including a plurality of interconnected flexible tubes and for controlling the flow of fluid through said interconnected flexible tubing means, each of said plurality of valve means including compression means controllably urgeable against selected flexible tubing means for at least partly closing the lumen thereof.

54. The apparatus of claim 40, further comprising sensor-support means in said first and second regions for supporting said first and second sensors, said sensor-support means being arranged and constructed for permitting transfer of said first sensor means to said second region for use in connection with said second module.

55. The apparatus of claim 40, wherein said indicator means is an alpha-numeric display.

56. The apparatus of claim 40, wherein said indicator means is a print-out.

57. The apparatus of claim 40, wherein said indicator means is a cathode ray tube.

58. The apparatus of claim 40, wherein said indicator means is a meter.

59. The apparatus of claim 40, wherein said indicator means is a light-emitting diode display.

60. The apparatus of claim 40, wherein said indicator means is a liquid crystal display.

61. The apparatus of claim 40, further comprising second tubing means in said first module, wherein said first and second sensor means are arranged and constructed for sensing flow rates in said first and second tubing means and said computer means is arranged and constructed for integrating said flow rates with time, comparing the resultant volumes, and said indicator means is arranged and constructed for indicating the difference therebetween and appropriate adjustment in at least one of said flow rates and of said selected procedure.

62. The apparatus of any of claims 40, 47 or 61, further comprising means for adjusting the value of said variables, and wherein said indicator means is a controller means for holding said variables within a selected range established by said selected program, said controller means being connected with said adjusting means for automatically holding said variables within said range.