Balanced physiological monitoring and treatment system

• US 8,956,291 B2
• Filed: 02/22/2006
• Issued: 02/17/2015
• Est. Priority Date: 02/22/2005
• Status: Active Grant

• Current Assignee: Admetsys Corporation
• Original Assignee: Admetsys Corporation
• Inventors: Valk, Jeffrey, Valk, Timothy
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/816,821
• Publication Number:
  US 20080194924A1
• Time in Patent Office: 3,282 Days
• Field of Search: 600/301, 600/369, 604/66
• US Class Current: 600/301
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for providing balanced, automated regulation of a patient'"'"'s physiological condition by monitoring at least one physiological parameter and, optionally, monitoring and controlling additional physiological parameters, is disclosed. The system includes a physiological parameter monitor, an intelligent control device and a multi-channel delivery device for providing controlled intravenous delivery of at least two medications that affect the physiological condition being controlled. Control logic in the intelligent control device is derived by an algorithm based on model predictive control. The control logic includes mathematically modeled systems, empirical data systems or a combination thereof. The system of the present invention is optionally included in a networked system to provide centralized data storage and archival of system information as well as data export and query capabilities that can be used for patient file management, health care facility management and medical research.

Claims

1. A system for monitoring and controlling a physiological condition of a patient, comprising:

at least one physiological parameter monitor adapted to monitor at least one physiological parameter of a patient;

a control device operably connected to said at least one physiological parameter monitor, said control device having adaptive control logic for adaptive optimization of patient-specific sensitivity to dosage by monitoring, receiving and storing physiological parameter data from said physiological parameter monitor and translating said physiological parameter data into an output control signal containing information regarding administration of at least two counterbalancing medications; and

a multi-channeled delivery mechanism operably connected to said control device, said delivery mechanism capable of receiving said output control signal from said control device,

said multi-channeled delivery mechanism being structured to infuses said at least two counterbalancing medications into the patient based on said information contained in said output control signal to adaptively stabilize and balance said physiological parameter of the patient,

wherein said patient-specific sensitivity to dosage of at least one of said at least two counterbalancing medications is analyzed by calculating a localized patient-specific sensitivity to at least one of said at least two medications, said localized patient-specific sensitivity calculated by comparing a measured rate of change in said physiological parameter to an expected rate of change in said physiological parameter.

2. The system of claim 1 wherein said physiological parameter monitor measures blood glucose level.

3. The system of claim 1 wherein said physiological parameter monitor measures blood coagulation status.

4. The system of claim 2 wherein said at least two medications infused into the patient are glucose and insulin.

5. The system of claim 3 wherein said at least two medications infused into the patient are a coagulant and an anti-coagulant.

6. The system of claim 5 wherein said coagulant is selected from the group consisting of extrinsic clotting factors, intrinsic clotting factors and clotting factor stimulants.

7. The system of claim 5 wherein said anti-coagulant is selected from the group consisting of vitamin K, urokinase, streptokinase, heparin and other direct and indirect clotting factor inhibitors.

8. The system of claim 1 wherein said at least one physiological parameter monitor comprises a first physiological parameter monitor configured to monitor blood pressure, a second physiological parameter monitor configured to monitor heart rate, a third physiological parameter monitor configured to monitor hemoglobin level, and a fourth physiological parameter monitor configured to monitor cardiac output and a fifth physiological parameter monitor configured to monitor arterial oxygen concentration and a sixth physiological parameter monitor configured to monitor at least one circulating factor from the group consisting of vasoactive and inflammatory factors.

9. The system of claim 8 wherein said at least two medications are selected from the group consisting of a vasodilator and a vasoconstrictor.

10. The system of claim 9 wherein said vasodilator is selected from a group consisting of nitric oxide, L-arginine, alpha blockers, beta agonists, potassium channel openers, calcium channel blockers, angiotensin inhibitors and phosphodiesterase inhibitors.

11. The system of claim 9 wherein said vasoconstrictor is selected from a group consisting of endothelin, endothelin compounds, sympathomimetics and vasopressin compounds.

12. The system of claim 1 wherein said control logic further an algorithm for monitoring and controlling said at least one physiological parameter, said algorithm configured to determine baseline dosage functions for said at least two counterbalancing medications;

determine expected response functions for said at least one physiological parameter to said at least two counterbalancing medications;

analyze the patient'"'"'s demonstrated response to said at least two counterbalancing medications to derive patient-specific sensitivity to said at least two counterbalancing medications; and

use said patient-specific sensitivity in conjunction with said baseline dosage functions to calculate patient-adapted dosages of said at least two counterbalancing medications.

13. The system of claim 12 wherein at least one of said baseline dosage functions is explicitly defined.

14. The system of claim 12 wherein at least one of said baseline dosage functions is calculated using data that characterize said baseline dosage function.

15. The system of claim 12 wherein at least one of said baseline dosage functions is selected from a group of baseline dosage functions based on data relating to patient attributes.

16. The system of claim 12 wherein at least one of said expected response functions is explicitly defined.

17. The system of claim 12 wherein at least one of said expected result functions is calculated from data that characterize said expected result function.

18. The system of claim 12 wherein at least one of said expected result functions is configured to change over time in reaction to detected events and patient conditions.

19. The system of claim 12 wherein said algorithm observes and classifies patterns in physiological behavior based on known patterns in physiological behavior using factors selected from the group consisting of physiological parameter data, patient-adapted dosages of said at least two counterbalancing medications, and patient-specific sensitivity to said at least two counterbalancing medications.

20. The system of claim 19 wherein said algorithm observes and identifies patterns in physiological behavior to define new known patterns using factors selected from the group consisting of physiological parameter data, patient-adapted dosages of said at least two counterbalancing medications, and patient-specific sensitivity to said at least two counterbalancing medications.

21. The system of claim 19 wherein said control logic is configured to alter said algorithm in response to classifying at least one of said patterns in physiological behavior based on said known patterns.

22. The system of claim 12 wherein said physiological parameter being monitored is blood glucose level.

23. The system of claim 12 wherein said physiological parameter being monitored is the patient'"'"'s blood coagulation status.

24. The system of claim 12 wherein said control logic monitors two or more physiological parameters in order to control the patient'"'"'s overall physiological stability.

25. The system of claim 24 wherein said control logic includes an empirical, mathematical model for calculating probability coefficients based on a data series of said physiological parameters being monitored, said probability coefficients are used to predict future values in said data series.

26. The system of claim 25 wherein said control logic calculates said patient-adapted dosage by using predictive modeling in conjunction with patient-specific sensitivity data.

27. The system of claim 24 wherein said physiological parameters are selected from the group consisting of blood pressure, heart rate, hemoglobin level, arterial oxygen concentration and cardiac output.

28. The system of claim 1 wherein said localized patient-specific sensitivity is calculated by comparing a measured rate of change in said physiological parameter over an interval of time to an expected rate of change in said physiological parameter over an interval of time.

29. The system of claim 28 wherein said patient-specific sensitivity to at least one of said at least two counterbalancing medications is further analyzed by calculating a cumulative patient-specific sensitivity to at least one of said at least two counterbalancing medications, said cumulative patient-specific sensitivity calculated by applying a weighted average to said localized patient-specific sensitivity over all know points in a series of patient data.

30. The system of claim 12 wherein said control device is configured to organize and permanently store data for analysis and research purposes, wherein said data comprises information related to said baseline dosage function, said expected response function, said patient'"'"'s demonstrated response, said patient-specific sensitivity and said patient-adapted dosage.

31. The system of claim 1 wherein said delivery mechanism comprises a plurality of infusion pumps.

32. The system of claim 31 wherein said delivery mechanism infuses a plurality of medications into the patient.

33. The system of claim 32 wherein said pumps are provided with variable speed drives to control a volumetric flow rate of said plurality of medications.

34. The system of claim 32 further comprising two control valves configured to control a volumetric flow rate of said plurality of medications delivered to the patient, said control valves operably connected to said infusion pumps.

35. The system of claim 1 further comprising said control device connected to a display device and at least one human interface device.

36. The system of claim 1 further comprising a network operably connected to said control device through a connection means, said connection means selected from the group consisting of wired connections and wireless connections.

37. The system of claim 36 wherein said control device is configured to access a network node, said network node configured to store patient specific data.

38. The system of claim 36 wherein a web server is operably connected to said control logic to provide remote access to system status and patient specific data over said network.

39. The system of claim 1 wherein said control device comprises a miniature chip configured to be implanted in the patient'"'"'s body.

40. The system of claim 39 wherein said delivery mechanism comprises an encapsulated medication that is pre-programmed to release on-demand based on information contained in said output control signal.

41. The system of claim 1 wherein said control device includes a permanent storage device configured to store patient specific data.

42. A method for monitoring and controlling a physiological condition of a patient, comprising:

monitoring at least one physiological parameter of a patient with a physiological parameter monitor;

providing a control device operably connected to said physiological parameter monitor, said control device including adaptive control logic for adaptive optimization of patient-specific sensitivity to dosage by monitoring, receiving and storing physiological parameter data from said physiological parameter monitor;

analyzing said patient-specific sensitivity by calculating a localized patient-specific sensitivity to dosage of at least one of at least two medications, said localized patient-specific sensitivity calculated by comparing a measured rate of change in said physiological parameter to an expected rate of change in said physiological parameter;

causing said control device to translate said data into an output control signal containing information regarding administration of said at least two counterbalancing medications;

sending said output control signal to a delivery manifold operably connected to said control device;

causing said delivery manifold to infuse said at least two counterbalancing medications into the patient based on said information contained in said output control signal to adaptively stabilize and balance said physiological condition of the patient.

43. The method of claim 42 further comprising monitoring a blood glucose level with said physiological parameter monitor.

44. The method of claim 43 further comprising causing said delivery manifold to infuse glucose and insulin into the patient.

45. The method of claim 42 further comprising monitoring a blood coagulation status with said physiological parameter monitor.

46. The method of claim 45 further comprising causing said delivery manifold to infuse a coagulant and an anti-coagulant into the patient.

47. The method of claim 46 wherein said coagulant is selected from the group consisting of extrinsic clotting factors, intrinsic clotting factors and clotting factor stimulants.

48. The method of claim 46 wherein said anti-coagulant is selected from the group consisting of vitamin K, urokinase, streptokinase, heparin and other direct and indirect clotting factor inhibitors.

49. The method of claim 42 further comprising providing a first physiological parameter monitor for monitoring the patient'"'"'s blood pressure, a second physiological parameter monitor for monitoring the patient'"'"'s heart rate, a third physiological parameter monitor for monitoring the patient'"'"'s hemoglobin level, a fourth physiological parameter monitor configured to monitor the patient'"'"'s cardiac output and a fifth physiological parameter monitor configured to monitor the patient'"'"'s arterial oxygen concentration and a sixth physiological parameter monitor configured to monitor at least one circulating factor from the group consisting of vasoactive and inflammatory factors.

50. The method of claim 49 further comprising causing said delivery manifold to infuse a vasodilator and a vasoconstrictor into the patient.

51. The method of claim 50 wherein said vasodilator is selected from a group consisting of nitric oxide, L-arginine, alpha blockers, beta agonists, potassium channel openers, calcium channel blockers, angiotensin inhibitors and phosphodiesterase inhibitors.

52. The method of claim 50 wherein said vasoconstrictor is selected from a group consisting of endothelin, endothelin compounds, sympathomimetics and vasopressin compounds.

53. The method of claim 42 wherein said control logic further comprises an algorithm for monitoring and controlling said at least one physiological parameter, said algorithm configured to determine baseline dosage functions for said at least two counterbalancing medications;

determine expected response functions for said physiological parameter to said at least two counterbalancing medications;

analyze said patient'"'"'s demonstrated response to said at least two counterbalancing medications to derive a patient-specific sensitivity to said at least two counterbalancing medications; and

use said patient-specific sensitivity in conjunction with said baseline dosage functions to calculate patient-adapted dosages of said at least two counterbalancing medications.

54. The method of claim 53 further comprising explicitly defining at least one of said baseline dosage functions.

55. The method of claim 53 further comprising calculating at least one of said baseline dosage functions using data that characterize said at least one baseline dosage function.

56. The method of claim 53 further comprising selecting at least one of said baseline dosage functions from a group of baseline dosage functions based on data relating to patient attributes.

57. The method of claim 53 further comprising explicitly defining at least one of said expected response functions.

58. The method of claim 53 further comprising calculating at least one of said expected result functions from data that characterize said at least one expected result function.

59. The method of claim 53 further comprising configuring at least one of said expected result functions to change over time in reaction to detected events and patient conditions.

60. The method of claim 53 further comprising said algorithm observing and classifying patterns in physiological behavior based on known patterns in physiological behavior using factors selected from the group consisting of physiological parameter data, patient-adapted dosages of said at least two counterbalancing medications, and patient-specific sensitivity to said at least two counterbalancing medications.

61. The method of claim 60 further comprising said algorithm observing and identifying patterns in physiological behavior to define new known patterns using factors selected from the group consisting of physiological parameter data, patient-adapted dosages of said at least two counterbalancing medications, and patient-specific sensitivity to said at least two counterbalancing medications.

62. The method of claim 60, further comprising altering said algorithm in response to classifying at least one of said patterns in physiological behavior based on said known patterns.

63. The method of claim 53, wherein said physiological parameter is blood glucose level.

64. The method of claim 63, wherein said physiological parameter is blood coagulation status.

65. The method of claim 53 further comprising organizing and permanently storing data for analysis and research purposes, wherein said data comprises information related to said baseline dosage function, said expected response function, said patient'"'"'s demonstrated response, said patient-specific sensitivity and said patient-adapted dosage.

66. The method of claim 42 further comprising calculating said localized patient-specific sensitivity by comparing a measured rate of change in said physiological parameter over an interval of time to an expected rate of change in said physiological parameter over an interval of time.

67. The method of claim 66, further comprising analyzing said patient-specific sensitivity to at least one said at least two counterbalancing medications by calculating a cumulative patient-specific sensitivity to at least one of said at least two counterbalancing medications by applying a weighted average to said localized patient-specific sensitivity over all known points in a series of patient data.

68. The method of claim 42, further comprising said control logic monitoring more than one physiological parameter in order to control the patient'"'"'s overall physiological stability.

69. The method of claim 68, further comprising calculating probability coefficients using an empirical, mathematical model based on a data series of said physiological parameters being monitored, wherein said probability coefficients are used to predict future values in said data series.

70. The method of claim 69 further comprising calculating said patient-adapted dosage by using predictive modeling in conjunction with patient-specific sensitivity data.

71. The method of claim 42, wherein said physiological parameters are selected from the group consisting of blood pressure, heart rate, hemoglobin level, arterial oxygen concentration and cardiac output.

72. The method of claim 42, wherein said delivery manifold comprises a plurality of infusion pumps capable of infusing a plurality of medications into the patient.

73. The method of claim 72, wherein said pumps include variable speed drives for controlling a volumetric flow rate of said plurality of medications.

74. The method of claim 72, wherein said plurality of infusion pumps are operably connected to a plurality of control valves for controlling a volumetric flow rate of the plurality of medications.

75. The method of claim 42 further comprising operably connecting said control device to a display device and at least one human interface device.

76. The method of claim 42 further comprising operably connecting a network to said control device through a connection means, said connection means selected from the group consisting of wired connections and wireless connections.

77. The method of claim 76 further comprising said control device accessing a network node, said network node stores patient-specific data.

78. The method of claim 76 further comprising operably connecting a web server to said control device to provide remote access to system status and patient-specific data over said network.

79. The method of claim 42 further comprising said control device having a permanent storage device therewithin, wherein said permanent storage device stores patient-specific data.

80. The method of claim 42 wherein said control device comprises a miniature chip configured to be implanted in a patient'"'"'s body.

81. The system of claim 80 wherein said delivery manifold comprises an encapsulated medication that is pre-programmed to release on-demand in response to said information contained in said output control signal.