Balanced physiological monitoring and treatment system

• US 9,421,332 B2
• Filed: 01/14/2015
• Issued: 08/23/2016
• Est. Priority Date: 02/22/2005
• Status: Active Grant

• Current Assignee: Admetsys Corporation
• Original Assignee: Admetsys Corporation
• Inventors: Valk, Jeffrey W., Valk, Timothy W.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/596,916
• Publication Number:
  US 20150157795A1
• Time in Patent Office: 587 Days
• US Class Current: 1/1
• 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 control logic for optimization of patient-specific sensitivity to dosage by monitoring, receiving and storing physiological parameter data generated 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 based on said patient-specific sensitivity to dosage; and

a multi-channeled delivery mechanism operably connected to said control device and capable of receiving said output control signal from said control device, said multi-channeled delivery mechanism being structured to infuse said at least two counterbalancing medications into the patient based on said patient-specific sensitivity to dosage information contained in said output control signal.

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

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

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

5. The system of claim 4 wherein said at least two counterbalancing medications are a coagulant and an anti-coagulant.

6. 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.

7. The system of claim 6 wherein said at least two counterbalancing medications are selected from the group consisting of a vasodilator and a vasoconstrictor.

8. The system of claim 1 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 the patient'"'"'s demonstrated response to said at least two counterbalancing medications to derive said 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.

9. The system of claim 8 wherein at least one of said baseline dosage functions is explicitly defined.

10. The system of claim 8 wherein at least one of said baseline dosage functions is calculated using data that characterize said baseline dosage function.

11. The system of claim 8 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.

12. The system of claim 8 wherein at least one of said expected response functions is explicitly defined.

13. The system of claim 8 wherein at least one of said expected result functions is calculated from data that characterize said expected result function.

14. The system of claim 8 wherein at least one of said expected result functions is configured to change over time in reaction to detected events and patient conditions.

15. The system of claim 8 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.

16. The system of claim 15 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.

17. The system of claim 16 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.

18. The system of claim 8 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 known points in a series of patient data.

19. The system of claim 8 wherein said control logic monitors two or more physiological parameters in order to control the patient'"'"'s overall physiological stability.

20. The system of claim 19 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 being used to predict future values in said data series.

21. The system of claim 20 wherein said control logic calculates said patient-adapted dosage by using predictive modeling in conjunction with patient-specific sensitivity data.

22. The system of claim 1 wherein said delivery mechanism comprises a plurality of infusion pumps configured to infuse a plurality of medications into the patient.