Hemodialysis patient data acquisition, management and analysis system

• US 9,370,324 B2
• Filed: 11/05/2008
• Issued: 06/21/2016
• Est. Priority Date: 11/05/2008
• 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: Barrett, Louis LeeGrande, Peterson, David Wayne, Nathanson, Brian Harris, Germain, Michael Jack, Black, Michael K.
• Primary Examiner(s): Dejong, Eric S
• Application Number:
  US12/265,386
• Publication Number:
  US 20100113891A1
• Time in Patent Office: 2,785 Days
• Field of Search: 604/403, 604/408, 604/411, 604/412, 604/414, 604/415, 604/416
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/207 hematocrit
• 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 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 : using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/592 : Communication of patient or blood pump data to distant operators for treatment purposes
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• 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 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A hemodialysis patient data acquisition and management system resides on a host computer which receives information from one or more non-invasive, optical blood monitors associated with a hemodialysis system. When a patient is undergoing hemodialysis treatment, a sensor assembly monitors the patient'"'"'s blood flowing through the hemodialysis system and a controller for the blood monitor generates data which includes at least an identification code for the patient undergoing the treatment on the respective system, and non-invasively determined blood data taken at the onset of the scheduled treatment, such as initial Hgb, HCT, and SAT values. A host computer communicates with the one or more optical blood monitors, preferably via a wireless network, and the patient'"'"'s session commencement data is downloaded to the host computer. The host computer includes a patient database containing historical session commencement data for a plurality of patients, as well as screen displays for displaying historical data for individual patients, such as Hgb trends. The system also preferably provides a predictive algorithm for the patient'"'"'s Hgb at the patient'"'"'s next scheduled hemodialysis treatment session. The preferred system also includes software that provides a recommended dose of the anemia management drug for the patient.

Claims

1. An anemia management system for hemodialysis patients comprising:

at least one hemodialysis system for drawing blood from a patient, passing the drawn blood through extracorporeal tubing and through a dialyzer, and returning the dialyzed blood through extracorporeal tubing to the patient, the hemodialysis system comprising;

a blood chamber having an inlet and an outlet which are connected in line with the extracorporeal tubing of the hemodialysis system and a fluid passageway through which the drawn blood flows;

a first photo emitter for emitting light at a first wavelength through the blood chamber and the drawn blood flowing through the blood chamber;

a second photo emitter for emitting light at a second wavelength through the blood chamber and the drawn blood flowing through the blood chamber; and

at least one photo detector for detecting the intensity of light at the first and second wavelength after it passes through the blood chamber and the drawn blood flowing through the blood chamber;

a computing system, connected to the at least one hemodialysis system, the computing system comprising processor-executable instructions, stored on one or more non-transitory processor-readable media, and one or more processors for executing the processor-executable instructions, wherein the processor-executable instructions include instructions for;

receiving a signal representing the detected light intensity levels from the at least one hemodialysis system;

determining a value representing the patient'"'"'s hemoglobin level based on the received signal;

storing the determined value in a patient database of the computing system;

determining, based on information stored in the patient database, a predicted value for the patient'"'"'s hemoglobin level at the onset of a next treatment session by applying a statistical model to stored patient data, where the predicted value is based on multiple instances of the patient'"'"'s previous hemoglobin levels corresponding to measurements taken at the onset of a series of treatment sessions, multiple coefficients determined based on the statistical model with each coefficient corresponding to one of the multiple instances of the patient'"'"'s previous hemoglobin levels, and at least one previously administered dosage of an erythropoiesis stimulating agent (ESA);

determining a recommended ESA dosage for the patient based on the predicted value; and

outputting the recommended ESA dosage via an output interface of the computing system.

2. The anemia management system as recited in claim 1, wherein the first photo emitter emits light at a wavelength of substantially 800 nm, and the second photo emitter emits light at a wavelength of substantially 1300 nm.

3. The anemia management system as recited in claim 1, wherein the computing system is further configured to determine a hematocrit value and an oxygen saturation value for the patient, as well as time and date information at the onset of the patient'"'"'s hemoglobin treatment session.

4. The anemia management system as recited in claim 3, wherein the at least the first and second photo emitters of the non-invasive blood monitor emit light at a wavelength of substantially 800 nm and substantially 1300 nm, respectively, and a third photo emitter emits light at a wavelength of substantially 660 nm.

5. The anemia management system as recited in claim 1, wherein determining the statistical model is a cross-sectional regression model based on statistical analysis of data collected from a plurality of hemodialysis patients over a number of hemodialysis treatment sessions being monitored by a non-invasive blood monitor.

6. The anemia management system as recited in claim 1, wherein determining the predicted value is based on the following equation:

Predicted Hgb Value=A*(Hgb of Last Period)+B*(Hgb of Second to Last Period)+C*(Hgb of Third to Last Period)+D*(Last ESA Dose value)+E

where Hgb of last period, Hgb of second to last period and Hgb of the third to last period represent the patients hemoglobin levels monitored at the previous three hemodialysis treatment sessions, the last ESA dose value represents the ESA dose administered to the patient at the patient'"'"'s last treatment session, the values A through E are statistical regression coefficients, and the predicted Hgb value represents the predicted value of the patient'"'"'s hemoglobin level at the start of the next treatment session.

7. The anemia management system as recited in claim 6, wherein the ESA is recombinant erythropoietin, and the regression coefficient A is substantially equal to 0.4784356, the regression coefficient B is substantially equal to 0.2042212, the regression coefficient C is substantially equal to 0.222685, the regression coefficient D is substantially equal to 0.0000396, and the regression coefficient E is substantially equal to 0.9627966.