Patient treatment and monitoring systems and methods with cause inferencing

• US 10,799,117 B2
• Filed: 02/15/2012
• Issued: 10/13/2020
• Est. Priority Date: 11/05/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Sands, Jeffrey J., Diaz-Buxo, Jose, Schlaeper, Christian, Crnkovich, Martin
• Primary Examiner(s): Sereboff, Neal
• Application Number:
  US13/397,265
• Publication Number:
  US 20130211206A1
• Time in Patent Office: 3,163 Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• 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 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• 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 2230/50 : Temperature
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

The invention provides a health care delivery system comprising a plurality of health care delivery devices (e.g., via the Internet, etc.), which can disposed in treatment centers ranging from patient homes to commercial health care facilities such as hospitals, dialysis centers and so forth. Reporting functionality can, instead of or in addition to identifying (and reporting on) discrepancies in the raw and/or analyzed data from the delivery devices, infer (and report) on possible causes of those discrepancies and, in some aspects of the invention, remedy those causes, thereby, providing automated operations support for the treatment centers.

Claims

1. A distributed dialysis care delivery system comprising:

a) a plurality of dialysis care delivery devices disposed at a plurality of treatment centers, each dialysis care delivery device comprising

(i) a processor and a storage device;

(ii) a dialysis treatment apparatus including sensors that sense (a) physiometric characteristics of a respective patient in connection with treatment by the dialysis treatment apparatus, and (b) operating conditions of any of the dialysis care delivery device and the dialysis treatment apparatus, wherein the sensors include one or more of blood pressure sensors, and any of zero, one or more of temperature sensors, pulse sensors, electrochemical sensors, fluid flow sensors, fluid temperature sensors, fluid level sensors, power sensors, maintenance status sensors,

wherein the processor receives information on the physiometric characteristics of the patient and the operating conditions from the sensors and signals alerts in response to blood pressure readings from the respective sensors and stores the information into the storage device, and

(iii) a network interface, wherein the processor coupled with the network interface transmits the physiometric characteristics and operating conditions through the network interface to a remote digital data processing system; and

b) the remote digital data processing system comprising

i) an analysis module that compares received information on physiometric characteristics and operating conditions received from the plurality of dialysis care delivery devices with any of (a) one another, (b) prior information received from the dialysis care delivery devices and/or from patient records, (c) one or more predetermined values on the physiometric characteristics and the operating conditions, to monitor treatment of patients and operating conditions of the medical treatment apparatus and to identify discrepancies in dialysis treatment at a said treatment center, and

ii) a reporting module that generates a report and signals an alert on determining that a said treatment center is not doing as expected,

iii) where the analysis module compares received information on physiometric characteristics from the plurality of dialysis care delivery devices with one another to cross-correlate blood pressure alerts respectively signaled by those devices with treatment information from others of those other devices, and

iv) wherein the reporting module displays an alarm on determining that a first said patient requires medication adjustment in light of deviation of a said cross-correlation by a designated chi-squared test threshold value over the course of a designated period, and wherein the reporting module effects changes in operation of the dialysis care delivery device of said first patent by making that adjustment.

2. The health care delivery system of claim 1, in which the analysis module (i) linearly infers, from patterns of hypotension reflected in data from the dialysis care delivery device, that patients under care by one or more of said dialysis care delivery

devices at a particular treatment center requires a “

dry weight”

adjustment based on difference of the patterns of hypotension over a specific period.

3. The health care delivery system of claim 1, in which the analysis module (i) linearly infers, from patterns of hypotension reflected in data from the dialysis care delivery device, that patients under care by one or more of said dialysis care delivery devices at a particular treatment center requires a medication adjustment based on difference of the patterns of hypotension over a specific period.

4. The health care delivery system of claim 1, in which the analysis module (i) linearly infers, from patterns of hypotension reflected in data from the dialysis care delivery device, that patients under care by one or more of said dialysis care delivery devices at a particular treatment center requires a filtration rate adjustment based on difference of the patterns of hypotension over a specific period.

5. The health care delivery system of claim 1, in which the analysis module (i) linearly infers, from patterns of hypotension reflected in data from the dialysis care delivery device, that patients under care by one or more of said dialysis care delivery devices at a particular treatment center requires an incoming/fresh dialysate temperature adjustment based on difference of the patterns of hypotension over a specific period.

6. The health care delivery system of claim 1, in which analysis module (i) linearly infers from patterns of hypotension reflected in data from the dialysis care delivery device that patients under care by one or more of said dialysis care delivery devices at a particular treatment center requires a hemocoagulant medication adjustment and/or vascular access evaluation based on difference of the patterns of hypotension over a specific period.

7. The device of claim 1, wherein the reporting module displays the alarm when the alerts generated by the first monitoring logic indicate that the first patient requires anti-coagulation medication adjustment in light of deviation of said cross-correlation by the designated chi-squared test threshold value over the course of designated period.

8. The device of claim 7, wherein a first said dialysis apparatus responds to signaling generated by the reporting module in connection with the alarm by modifying an amount of anticoagulant infused into dialysates in connection with treatment of the first patient by that apparatus.

9. A distributed dialysis care delivery system comprising:

a) a plurality of dialysis care delivery devices disposed at a plurality of treatment centers, each dialysis care delivery device comprising

(i) a processor and a storage device;

(ii) a dialysis treatment apparatus including sensors that sense (a) physiometric characteristics of a respective patient in connection with treatment by the dialysis treatment apparatus, and (b) operating conditions of any of the dialysis care delivery device and the dialysis treatment apparatus, wherein the sensors include one or more of blood pressure sensors, and any of zero, one or more of temperature sensors, pulse sensors, electrochemical sensors, fluid flow sensors, fluid temperature sensors, fluid level sensors, power sensors, maintenance status sensors,

wherein the processor receives information on the physiometric characteristics of the patient and the operating conditions from the sensors and signals alerts in response to blood pressure readings from the respective sensors and stores the information into the storage device, and

(iii) a network interface, wherein the processor coupled with the network interface transmits the physiometric characteristics and operating conditions through the network interface to a remote digital data processing system; and

b) the remote digital data processing system comprising

i) an analysis module that compares received information on physiometric characteristics and operating conditions received from the plurality of dialysis care delivery devices with any of (a) one another, (b) prior information received from the dialysis care delivery devices and/or from patient records, (c) one or more predetermined values on the physiometric characteristics and the operating conditions, to monitor treatment of patients and operating conditions of the medical treatment apparatus and to identify discrepancies in dialysis treatment at a said treatment center, and

ii) a reporting module that generates a report and signals an alert on determining that a said treatment center is not doing as expected,

iii) where the analysis module compares received information on physiometric characteristics from the plurality of dialysis care delivery devices with one another to cross-correlate blood pressure alerts respectively signaled by those devices with treatment information from others of those other devices, and

iv) wherein the reporting module displays an alarm on determining that a first said patient requires a filtration rate adjustment in light of deviation of a said cross-correlation by a designated chi-squared test threshold value over the course of a designated period, and wherein the reporting module effects changes in operation of the dialysis care delivery device of said first patent by making that adjustment.

10. The device of claim 9, wherein a said first dialysis apparatus responds to signaling generated by the reporting logic in connection with the alarm by modifying a filtration rate in connection with treatment of the first patient by that apparatus.

11. A device, comprising:

A) a first sensor to take blood pressure readings of a first patient in connection with treatment rendered by a first dialysis apparatus,

B) first monitoring logic coupled to the first sensor to signal alerts in response to blood pressure readings from the sensor,

C) a plurality of additional monitoring logics, each coupled to a respective sensor that takes blood pressure readings of a respective additional patient in connection with treatment rendered thereto by a respective additional dialysis apparatus, and each that signals alerts in response to blood pressure readings from the respective sensor,

D) analysis logic in communications coupling with the first monitoring logic and with the plurality of additional monitoring logics to cross-correlate blood pressure alerts signaled by the first monitoring logic for the first patient with blood pressure alerts signaled by the plurality of additional monitoring logics for the additional patients,

E) reporting logic to display an alarm when the alerts generated by the first monitoring logic indicate that the first patient requires medication adjustment in light of deviation of said cross-correlation by a designated chi-squared test threshold value over the course of designated period, and wherein the reporting logic effects changes in operation of the first dialysis apparatus by making that adjustment.

12. The device of claim 11, wherein the reporting logic displays the alarm when the alerts generated by the first monitoring logic indicate that the first patient requires anti-coagulation medication adjustment in light of deviation of said cross-correlation by the designated chi-squared test threshold value over the course of designated period.

13. The device of claim 11, wherein the first dialysis apparatus responds to signaling generated by the reporting logic in connection with the alarm by modifying an amount of anticoagulant infused into dialysates in connection with treatment of the first patient by that apparatus.

14. A device, comprising:

A) a first sensor to take blood pressure readings of a first patient in connection with treatment rendered by a first dialysis apparatus,

B) first monitoring logic coupled to the first sensor to signal alerts in response to blood pressure readings from the sensor,

C) a plurality of additional monitoring logics, each coupled to a respective sensor that takes blood pressure readings of a respective additional patient in connection with treatment rendered thereto by a respective additional dialysis apparatus, and each that signals alerts in response to blood pressure readings from the respective sensor,

D) analysis logic in communications coupling with the first monitoring logic and with the plurality of additional monitoring logics to cross-correlate blood pressure readings signaled by the first monitoring logic for the first patient with blood pressure readings signaled by the plurality of additional monitoring logics for the additional patients,

E) reporting logic to display an alarm when the alerts generated by the first monitoring logic indicate that the first patient requires a filtration rate adjustment in light of deviation of said cross-correlation by a designated chi-squared test threshold value over the course of designated period, and wherein the reporting logic effects changes in operation of the first dialysis apparatus by making that adjustment.

15. The device of claim 14, wherein the first dialysis apparatus responds to signaling generated by the reporting logic in connection with the alarm by modifying a filtration rate in connection with treatment of the first patient by that apparatus.