System and method of modeling erythropoiesis and its management

• US 10,319,478 B2
• Filed: 09/07/2012
• Issued: 06/11/2019
• Est. Priority Date: 09/08/2011
• 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: Fuertinger, Doris Helene, Kappel, Franz, Kotanko, Peter, Levin, Nathan W., Thijssen, Stephan
• Primary Examiner(s): Harward, Soren
• Application Number:
  US14/343,464
• Publication Number:
  US 20140200181A1
• Time in Patent Office: 2,468 Days
• Field of Search: None
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: G16C 20/30 Prediction of properties of chemical compounds, compositions or mixtures
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 50/80 for detecting, monitoring or modelling epidemics or pandemics, e.g. flu

Abstract

A method of adjusting a patient'"'"'s undesired hematocrit and/or hemoglobin concentration to a value within a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen includes obtaining patient parameters required for input into a model for predicting the patient'"'"'s hematocrit and/or hemoglobin concentration at a predetermined time with a selected ESA administration regimen, and employing the patient parameters and an initially selected EPO administration regimen in the model to predict the patient'"'"'s hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen. Optionally, if the patient'"'"'s hematocrit and/or hemoglobin concentration is not predicted by the model to be in the desired range at the predetermined time, the method includes employing the model with one or more different ESA administration regimens until the model predicts that the patient'"'"'s hematocrit and/or hemoglobin concentration will be in the desired range at the predetermined time. The method then includes administering ESA to the patient with an ESA administration regimen predicted to adjust the patient'"'"'s hematocrit and/or hemoglobin concentration to the desired range at the predetermined time. The method can be implemented in a computer system for adjusting a patient'"'"'s undesired hematocrit and/or hemoglobin concentration to a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen.

Claims

1. A method of adjusting a patient'"'"'s undesired hematocrit and/or hemoglobin concentration to a value within a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen comprising:

a) obtaining patient parameters required for input into a model for predicting the patient'"'"'s hematocrit and/or hemoglobin concentration at a predetermined time with a selected ESA administration regimen;

b) employing the patient parameters and an initially selected ESA administration regimen in the model to predict the patient'"'"'s hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen, wherein the model comprises the functions;

2. The method of claim 1, wherein the patient parameters include starting hematocrit and/or hemoglobin concentration in the patient'"'"'s blood, total blood volume of the patient, lifespan of red blood cells (RBCs) of the patient, mean corpuscular volume of the RBCs, and rate of neocytolysis in the patient'"'"'s blood.

3. The method of claim 1, wherein the predetermined time is in a range of between about 5 days and about 200 days into the ESA administration regimen.

4. The method of claim 1, wherein the patient is a dialysis patient and the desired hematocrit is in the range of between about 28 percent and about 36 percent and the desired hemoglobin concentration is in a range of between about 9.5 g/dL and about 12 g/dL.

10. The method of claim 1, wherein the patient undergoes a medical procedure prior to, during, or after initiation of the ESA administration regimen, the medical procedure selected from the group consisting of blood donation, surgery, and dialysis, or any combination thereof.

5. A system for adjusting a patient'"'"'s undesired hematocrit and/or hemoglobin concentration to a value within a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen the system comprising:

a) an input means for determining patient parameters of the patient;

b) a digital processor coupled to receive determined patient data from the input means, wherein the digital processor executes a modeling system in working memory, wherein the modeling system is configured to;

i) employ the patient parameters and an initially selected ESA administration regimen in the model to predict the patient'"'"'s hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen, wherein the model comprises the functions;

6. The system of claim 5, wherein the patient parameters include starting hemoglobin concentration in the patient'"'"'s blood, total blood volume of the patient, lifespan of red blood cells (RBCs) of the patient, mean corpuscular volume of the RBCs, and rate of neocytolysis in the patient'"'"'s blood.

7. The system of claim 5, wherein the predetermined time is in a range of between about 5 days and about 200 days into the ESA administration regimen.

8. The system of claim 5, wherein the patient is a dialysis patient and the desired hematocrit is in the range of between about 28 percent and about 36 percent and the desired hemoglobin concentration is in a range of between about 9.5 g/dL and about 12 g/d L.

9. A method of determining an erythropoiesis stimulating agent (ESA) administration regimen to bring a patient'"'"'s hematocrit and/or hemoglobin concentration into a desired range at a predetermined time comprising:

a) obtaining patient parameters required for input into a model for predicting the patient'"'"'s hematocrit and/or hemoglobin concentration at a predetermined time with a selected ESA administration regimen;

b) employing the patient parameters and an initially selected ESA administration regimen in the model to predict the patient'"'"'s hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen, wherein the model comprises the functions;