THERAPY PREDICTION AND OPTIMIZATION FOR RENAL FAILURE BLOOD THERAPY, ESPECIALLY HOME HEMODIALYSIS

• US 20120029324A1
• Filed: 04/15/2011
• Published: 02/02/2012
• Est. Priority Date: 04/16/2010
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Akonur, Alp, Leypoldt, John Kenneth, Lo, Ying-Cheng, Agar, Baris Ugur
• Granted Patent: US 8,845,570 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

A method of predicting serum phosphorus concentrations in a patient during hemodialysis includes measuring serum phosphorus concentrations of the patient over a hemodialysis treatment session time and an ultrafiltration rate calculated by a difference between pre- and post-dialytic body weight of the patient during an initial hemodialysis treatment session divided by a total treatment time of the treatment session and estimating a phosphorous mobilization clearance and a pre-dialysis distribution volume of phosphorus for the patient. Serum phosphorus concentrations of the patient can then be predicted at any time during any hemodialysis treatment session with the estimated phosphorous mobilization clearance and pre-dialysis distribution volume of phosphorus of the patient.

Claims

1. A renal failure blood therapy system comprising:

a renal failure blood therapy machine;

a therapy prescription for a patient treated by the renal failure blood therapy machine to remove a solute from the patient'"'"'s blood;

a test including multiple blood samples taken at multiple times during a test therapy to determine concentration levels of the solute at each of the multiple times; and

a device programmed to use a kinetic model for the solute (i) in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter and (ii) in a second instance with the at least one estimated patient parameter and a desired therapy result for the solute to determine at least one of a therapy duration, a therapy frequency, a dialysate flowrate or a blood flowrate for the therapy prescription.

2. The renal failure blood therapy system of claim 1, wherein the therapy prescription is stored in a memory of the renal failure blood therapy machine.

3. The renal failure blood therapy system of claim 1, wherein at least one of (i) the renal failure blood therapy machine is a home hemodialysis machine, (ii) the device includes a doctor computer, or (iii) the home hemodialysis machine is in data-networked communication with the doctor computer.

4. The renal failure blood therapy system of claim 1, wherein the device in the first instance is programmed to use each of the concentration levels of the solute to estimate the at least one estimated patient parameter.

5. The renal failure blood therapy system of claim 1, wherein the device in the first instance is programmed to use a combination of the concentration levels of the solute to estimate the at least one estimated patient parameter.

6. The renal failure blood therapy system of claim 1, wherein the device in the first instance is programmed to use the at least one of the concentration levels of the solute to estimate a plurality of different estimated patient parameters.

7. The renal failure blood therapy system of claim 1, wherein the device in the first instance is programmed to use the at least one estimated patient parameter and the desired therapy result for the solute to determine a plurality of therapy duration and therapy frequency combinations that satisfy the desired therapy result.

8. The renal failure blood therapy system of claim 7, wherein at least one of the satisfactory therapy duration and therapy frequency combinations is selected for use with the renal failure blood therapy machine.

9. The renal failure blood therapy system of claim 1, wherein the at least one estimated patient parameter is selected from the group consisting of:

generation rate (G), cellular diffusion coefficient (K_IC), and solute distribution volume (V_D).

10. The renal failure blood therapy system of claim 1, wherein the device is additionally programmed to use at least one inputted machine operating parameter in performing at least one of (i) or (ii).

11. The renal failure blood therapy system of claim 10, wherein the at least one machine operating parameter is selected from the group consisting of:

blood flowrate, dialysate flowrate, dialysate total volume, ultrafiltration flowrate and ultrafiltration volume.

12. The renal failure blood therapy system of claim 1, the solute a first solute, the kinetic model a first kinetic model, and which includes a plurality of solutes and corresponding kinetic models, the device programmed to use each of the kinetic models (i) in the first instance with at least one of the concentration levels of the corresponding solute to estimate at least one estimated patient parameter and (ii) in the second instance with the at least one estimated patient parameter and the desired therapy result for the corresponding solute to determine at least one of the therapy duration or the therapy frequency for the therapy prescription.

13. The renal failure blood therapy system of claim 12, wherein the device is further programmed to allow an operator to select which of the solutes, corresponding kinetic models and desired therapy results to include in (ii).

14. The renal failure blood therapy system of claim 12, wherein one of the solutes is phosphate, its corresponding kinetic model assuming mobilization of phosphate to be proportional to a difference between the instantaneous and pre-therapy phosphate concentrations.

15. A renal failure blood therapy system comprising:

a renal failure blood therapy machine;

a therapy prescription for a patient treated by the renal failure blood therapy machine to remove a solute from the patient'"'"'s blood;

a test including multiple blood samples taken at multiple times during a test therapy to determine concentration levels of the solute at each of the multiple times; and

a device programmed to use a kinetic model for the solute (i) in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter and (ii) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict a therapy result for the parameter.

16. The renal failure blood therapy system of claim 15, wherein the device is additionally programmed to use at least one inputted machine operating parameter in at least one of (i) or (ii).

17. The renal failure blood therapy system of claim 16, wherein the at least one machine operating parameter is selected from the group consisting of:

blood flowrate, dialysate flowrate, dialysate total volume, ultrafiltration flowrate and ultrafiltration volume.

18. The renal failure blood therapy system of claim 15, wherein the solute is a first solute, the kinetic model a first kinetic model, and which includes a plurality of solutes and corresponding kinetic models, the device programmed to use each of the kinetic models (i) in a first instance with at least one of the concentration levels of the corresponding solute to estimate at least one estimated patient parameter and (ii) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict therapy result for the parameter.

19. The renal failure blood therapy system of claim 18, the device further programmed to allow an operator to select which of the solutes and corresponding kinetic model and desired therapy result to include in (ii).

20. A renal failure blood therapy system comprising:

a renal failure blood therapy machine;

a therapy prescription for a patient treated by the renal failure blood therapy machine to remove a solute from the patient'"'"'s blood;

a test including multiple blood samples taken at multiple times during a test therapy to determine concentration levels of the solute at each of the multiple times; and

a device programmed to use a kinetic model for the solute in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter, the device further programmed to enable a user to select between using the kinetic model for the solute (i) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict therapy result for the parameter, or (ii) in a second instance with the at least one estimated patient parameter and a desired therapy result for the solute to determine at least one of a therapy duration, a therapy frequency, a dialysate flowrate or a blood flowrate for the therapy prescription.

21. A device for use with a renal failure blood therapy machine running a therapy prescription for treating a patient to remove a solute from the patient'"'"'s blood, wherein the patient undergoes a test including multiple blood samples taken during a test therapy to determine concentration levels of the solute at each of the multiple times, the device comprising:

processing and memory programmed to use a kinetic model for the solute (i) in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter and (ii) in a second instance with the at least one estimated patient parameter and a desired therapy result for the solute to determine at least one of a therapy duration, a therapy frequency, a dialysate flowrate or a blood flowrate for the therapy prescription.

22. A device for use with a renal failure blood therapy machine running a therapy prescription for treating a patient to remove a solute from the patient'"'"'s blood, wherein the patient undergoes a test including multiple blood samples taken during a test therapy to determine concentration levels of the solute at each of the multiple times, the device comprising:

processing and memory programmed to use a kinetic model for the solute (i) in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter and (ii) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict a therapy result for the parameter.

23. A device for use with a renal failure blood therapy machine running a therapy prescription for treating a patient to remove a solute from the patient'"'"'s blood, wherein the patient undergoes a test including multiple blood samples taken during a test therapy to determine concentration levels of the solute at each of the multiple times, the device comprising:

processing and memory programmed to use a kinetic model for the solute in a first instance with at least one of the concentration levels of the solute to estimate at least one estimated patient parameter, the device further programmed to enable a user to select between using the kinetic model for the solute (i) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict therapy result for the parameter, or (ii) in a second instance with the at least one estimated patient parameter and a desired therapy result for the solute to determine at least one of a therapy duration, a therapy frequency, a dialysate flowrate or a blood flowrate for the therapy prescription.

24. A device for use with a renal failure blood therapy machine running a therapy prescription for treating a patient to remove a solute from the patient'"'"'s blood, wherein the concentration level for the solute is estimated for the patient based on a plurality of physical characteristics of the patient, the device comprising:

processing and memory programmed to use a kinetic model for the solute in a first instance with concentration level of the solute to estimate at least one estimated patient parameter, the device further programmed to enable a user to use the kinetic model for the solute (i) in a second instance with the at least one estimated patient parameter and at least one of a therapy duration or a therapy frequency to predict therapy result for the parameter, or (ii) in a second instance with the at least one estimated patient parameter and a desired therapy result for the solute to determine at least one of a therapy duration, a therapy frequency, a dialysate flowrate or a blood flowrate for the therapy prescription.

25. A method for use with a renal failure therapy, the method comprising:

testing a patient calculating a patient-specific parameter using a result of the testing and a kinetic model for a solute removed by the renal failure therapy;

calculating a value for the solute by entering the patient-specific parameter and a machine operational parameter into the kinetic model;

or

calculating a machine operational parameter by entering the patient-specific parameter and a value for the solute into the kinetic model.