IP Library › Granted Patent US 12,594,366
Granted Patent B2
US 12,594,366 · App. 16/574,874 · Granted Apr 7, 2026

Techniques for dialysis based on relative blood volume

Inventors: Doris H. Fuertinger (Long Island City, NY); Peter Kotanko (New York, NY); Sabrina Rogg (Bad Homburg, DE)
Assignees: Fresenius Medical Care Holdings, Inc.; Fresenius Medical Care Deutschland GmbH
A61M1/1611A61M1/1613A61M1/308A61M1/3441A61M2230/207
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,594,366
App. No.
16/574,874
Granted
Apr 7, 2026
Kind
B2
Abstract

Systems, methods, and/or apparatuses may be operative to perform a dialysis process using RBV-based UF control. Embodiments may include methods operative to receive RBV target information comprising population-based dialysis data of real patient outcomes of a patient population associated with the patient, determine an RBV value of a patient during the dialysis process, and determine UF information to control a UF pump of the dialysis device to maintain the RBV value within a target RBV range defined by the RBV target information. Other embodiments are described.

Claims (22)

1 . A method comprising:

performing a hemodialysis (HD) treatment on a patient using a dialysis machine;

determining a target ultrafiltration rate (UFR) using a computing device operably coupled to the dialysis machine, the computing device comprising a memory storing instructions and a processor, responsive to executing the instructions, operative to determine the target UFR via:

determining RBV target information for the patient based on population-based dialysis data of real patient outcomes of a patient population sharing at least one characteristic of the patient, the RBV target information comprising desired RBV target ranges for the patient during the dialysis process;

measuring relative blood volume (RBV) values of the patient during the dialysis treatment;

comparing the RBV values to the RBV target information;

determining the target UFR to maintain future RBV values of the patient during the dialysis treatment within the RBV target ranges; and

communicating the target UFR to the dialysis machine; and

controlling a UFR of the dialysis machine to correspond to the target UFR during the HD treatment.

2 . The method of claim 1 , comprising determining the UFR based on at least one constraint, the at least one constraint comprising at least one of: a maximum UF rate (UFR) change, oxygen saturation, blood pressure, or IDH prediction.

3 . The method of claim 2 , the maximum UFR rate change determined based on one of an elapsed time of the dialysis process or whether the RBV value is within the favorability tube or outside of the favorability tube.

4 . The method of claim 1 , further comprising determining the RBV target information based on Cox proportional hazard models with spline terms on the population-based dialysis data of a patient population sharing the at least one characteristic.

5 . The method of claim 1 , wherein the population-based dialysis data includes RBV ranges for improved patient outcomes based on factors including one or more of hazard ratios, morbidity values, mortality values, or complication rates.

6 . The method of claim 1 , wherein the patient population includes a patient population of a clinical trial.

7 . The method of claim 1 , wherein the characteristic of the patient includes one or more of age, gender, disease state, fluid removal volume, or complications.

8 . The method of claim 1 , wherein the desired RBV target ranges are determined based on one or more optimal target RBV curves.

9 . The method of claim 1 , wherein measuring the RBV values of the patient incudes obtaining the RBV values of the patient using a patient monitoring device.

10 . The method of claim 1 , wherein the RBV values of the patient are determined based on patient hematocrit values.

11 . The method of claim 1 , wherein controlling the UFR of the dialysis machine includes controlling a UF pump of the dialysis machine.

12 . The method of claim 1 , wherein controlling the UFR of the dialysis machine includes control circuitry of a UF pump of the dialysis machine:

receiving the target UFR; and

adjusting operation of the UF pump to achieve the target UFR.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 25, 2025
From: KOTANKO, PETER
To: FRESENIUS MEDICAL CARE HOLDINGS, INC.
Reel/Frame 073027/0544 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 24, 2025
From: FUERTINGER, DORIS H.; ROGG, SABRINA
To: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
Reel/Frame 073018/0164 →
Continuity (2)
Provisional Application 62733485 · Sep 19, 2018
Related Publication 20200086026A1 · Mar 19, 2020
References Cited (89)
US 11253638B2 · Steger et al. · 2022 [cited by applicant]
US 20030152482A1 · O'Mahony · 2003 [cited by examiner]
US 20110036773A1 · Moissl et al. · 2011 [cited by applicant]
US 20130041684A1 · Kotanko · 2013 [cited by applicant]
US 20130134077A1 · Wieskotten · 2013 [cited by applicant]
US 20130261529A1 · O'Mahony · 2013 [cited by applicant]
US 20130274644A1 · Hertz · 2013 [cited by applicant]
US 20130317850A1 · Bene · 2013 [cited by applicant]
US 20150045633A1 · Berkow · 2015 [cited by applicant]
US 20150065826A1 · Mulligan · 2015 [cited by applicant]
US 20170228509A1 · Ahrens · 2017 [cited by applicant]
US 20170239409A1 · De los Reyes, V · 2017 [cited by examiner]
US 20190200921A1 · Barrett · 2019 [cited by examiner]
CN 107224624A · 2017 [cited by applicant]
EP 2469431 · 2012 [cited by applicant]
JP S61203972A · 1986 [cited by applicant]
JP 2001000540A · 2001 [cited by applicant]
JP 2010063644A · 2010 [cited by applicant]
WO 2015179401A1 · 2015 [cited by applicant]
Flythe et al.Kidney International (2011) 79, 250-257 (Year: 2011). [cited by examiner]
Control System Designs—PID Control by Astrom et al., Department of Automatic Control LTH, Lund University, 2006 (Year: 2006). [cited by examiner]
Andrulli S, et al., “The role of blood volume reduction in the genesis of intradialytic hypotension”, Am J Kidney Dis 40(6):1244-1254 (2002). [cited by applicant]
Flythe, JE., et al., “Association of mortality risk with various definitions of intradialytic hypotensio,” J Am Soc Nephrol 26:724-734 (2015). [cited by applicant]
Malhotra R., et al., “Relationship of neutrophil-to-lymphocyte ratio and serum albumin levels with C-reactive protein in hemodialysis patients: results from 2 international cohort studies,” Nephron 1(30):263-270 (2015). [cited by applicant]
Flythe JE, et al., “Associations of posthemodialysis weights above and below target weight with all-cause and cardiovascular mortality”, Clin J Am Soc Nephrol 10:808-816 (2015). [cited by applicant]
Chazot C, et al., “Importance of normohydration for the long-term survival of haemodialysis patients”, Nephrol Dial Transplant 27:2404-2410 (2012). [cited by applicant]
Daugirdas JT., “Pathophysiology of dialysis hypotension: an update”, Am J Kidney Dis 38(4):S11-S17 (2001). abstract. [cited by applicant]
De los Reyes V AA, et al., “A physiologically based model of vascular refilling during ultrafiltration in hemodialysis”, J Theor Biol 390:146-155 (2016). abstract. [cited by applicant]
Paguio VME, et al., “A model of vascular refilling with inflammation,” Math Biosci 303:101-114 (2018). abstract. [cited by applicant]
Lopot F, et al., “Use of continuous blood vol. monitoring to detect inadequately high dry weight,” Int J Artif Organs 19:411-414 (1996).abstract. [cited by applicant]
Beige J, et al., “Computational analysis of blood vol. curves and risk of intradialytic morbid events in hemodialysis.” Kidney Int 58:1805-1809 (2000). [cited by applicant]
Howard, AD et al., “Assessing the value of blood vol. monitoring to improve outcomes. A comparative observational study”, Nephrol News Issues 12(5):24-26 (1998) abstract. [cited by applicant]
Agarwal, R., “Hypervolemia is associated with increased mortality among hemodialysis patients”, Hypertension 56:512-517 (2010). [cited by applicant]
Agarwal, R, et al., “Diagnostic utility of blood vol. monitoring in hemodialysis patients,” AmJ Kidney Dis 51(2): 242-254 (2008) abstract. [cited by applicant]
Krepel, HP., et al., “Variability of relative blood vol. during haemodialysis”,.Nephrol Dial Transplant 15:673-679 (2000). [cited by applicant]
Booth, J., et al., “Do changes in relative blood vol. monitoring correlate to hemodialysis-associated hypotension?” Nephron Clin Pract 117:c179-c183 (2011). [cited by applicant]
Steuer, R.R., et al., “ Enhanced fluid removal guided by blood vol. monitoring during chronic hemodialysis,” Artif Organs 22(8):627-632 (1998). abstract. [cited by applicant]
Canaud, B., et al., “Clinical practices and outcomes in elderly hemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS),” Clin J Am Soc Nephrol 6:1651-1662 ( 2011). [cited by applicant]
Rottembourg, J., et al., “Evolution of residual renal function in patients undergoing maintenance haemodialysis or continuous ambulatory peritoneal dialysis,” Proc Eur Dial Transplant Assoc 19:397-403 (1983). abstract. [cited by applicant]
Gil, H-W, et al. “Efficacy of Hemocontrol Biofeedback System in Intradialytic Hypotension-Prone Hemodialysis Patients,” Journal of Korean Medical Science, 29(6):805-10 (2014). [cited by applicant]
Levin, N.W., et al. “Hemodynamic response to fluid removal during hemodialysis: categorization of causes of intradialytic hypotension.” Nephrology Dial Transplant 33:1643-1649 (2018). [cited by applicant]
Sands, J.J., et al., “Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome,” Hemodialysis international International Symposium on Home Hemodialysis, 18(2):415-22 (2014). abst… [cited by applicant]
Preciado ,P., et al., “All-cause mortality in relation to changes in relative blood volume during hemodialysis,” Nephrology Dial Transplant 34:1401-1408 (2018). [cited by applicant]
Covic, A., & Onofriescu, M., “Time to Improve Fluid Management in Hemodialysis: Should We Abandon Clinical Assessment and Routinely Use Bioimpedance?” Clinical Journal of the American Society of Nephrology, 8(9):1474-5 … [cited by applicant]
Van der Sande, F.M, et al., “Novel Insights into the Pathogenesis and Prevention of Intradialytic Hypotension,” Blood Purification, 45(1-3):230-5 (2018). [cited by applicant]
Orofino, L., et al. “Epidemiology of Symptomatic Hypotension in Hemodialysis: Is Cool Dialysate Beneficial for All Patients?”, American Journal of Nephrology 10(3):177-80 (1990). abstract. [cited by applicant]
Burton, J.O., et al., “Hemodialysis-Induced Left Ventricular Dysfunction is Associated with an Increase in Ventricular Arrhythmias,” Renal Failure 30(7):701-9 (2008). [cited by applicant]
Burton, J.O., et al., “Hemodialysis-Induced Cardiac Injury: Determinants and Associated Outcomes,” Clinical Journal of Am Soc Nephrol 4(5):914-20 (2009). [cited by applicant]
Shoji, T., et al., “Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients,” Kidney International 66:1212-20 (2004). [cited by applicant]
Keane, D.F., et al., “Time to Reconsider the Role of Relative Blood Volume Monitoring for Fluid Management in Hemodialysis,” American Society for Artificial Internal Organs 64(6):812-818 (2018). [cited by applicant]
Dasselaar J.J., et al., “Relative blood vol. measurements during hemodialysis: Comparisons between three noninvasive devices,” Hemodialysis International Symposium on Home Hemodialysis. 11(4):448-5 (2007). abstract. [cited by applicant]
Basile C., et al. “Efficacy and Safety of Haemodialysis Treatment with the Hemocontrol Biofeedback System: A Prospective Medium-Term Study”, Nephrol Dial Transplant 16(2):328-334 (2001). [cited by applicant]
Begin V., et al., “Biofeedback regulation of ultrafiltration and dialysate conductivity for the prevention of hypotension during hemodialysis”, American Society for Artificial Internal Organs, 48(3):312-5. ( May-Jun. 20… [cited by applicant]
Ronco C., et al., “Impact of biofeedback-induced cardiovascular stability on hemodialysis tolerance and efficiency.” Kidney international, 58(2):800-808 (2000). [cited by applicant]
Santoro A., et al., “Blood vol. controlled hemodialysis in hypotension-prone patients: A randomized, multicenter controlled trial.” Kidney international, 62(3):1034-45 (2002). [cited by applicant]
Santoro A., et al. “Blood vol. Regulation During Hemodialysis.” American Journal of Kidney Diseases, 32(5):739-48 (1998). abstract. [cited by applicant]
Reddan, D.N., et al. “Intradialytic Blood vol. Monitoring in Ambulatory Hemodialysis Patients: A Randomized Trial”, Journal of the American Society of Nephrology, 16(7):2162-9 (2005). [cited by applicant]
Santoro A., et al., “Automatic Control of Blood vol. Trends During Hemodialysis” , American Society for Artificial Internal Organs, 40(3):M419-22, (1994). [cited by applicant]
Leung K.C.W., et al., “Randomized Crossover Trial of Blood Volume Monitoring-Guided Ultrafiltration Biofeedback to Reduce Intradialytic Hypotensive Episodes with Hemodialysis”, Clinical Journal of the American Society o… [cited by applicant]
Deziel C., et al., “Impact of Hemocontrol on Hypertension, Nursing Interventions, and Quality of Life: A Randomized, Controlled Trial”, Clinical Journal of the American Society of Nephrology, 2(4):661-8 (2007). [cited by applicant]
Gabrielli D., et al., “Improved intradialytic stability during haemodialysis with blood volume-controlled ultrafiltration”, Journal of Nephrology, 22(2):232-40 (2009). abstract. [cited by applicant]
Locatelli F., et al. “Effect of a plasma sodium biofeedback system applied to HFR on the intradialytic cardiovascular stability. Results from a randomized controlled study.” Nephrology, dialysis, transplantation: offici… [cited by applicant]
Mancini E., et al., “Prevention of dialysis hypotension episodes using fuzzy logic control system.” Nephrol Dial Transplant 22(5):1420-7 (2007). [cited by applicant]
Nesrallah G.E., et al.“Can Extracellular Fluid vol. Expansion in Hemodialysis Patients be Safely Reduced Using the Hemocontrol Biofeedback Algorithm? A Randomized Trial”, American Society for Artificial Internal Organs,… [cited by applicant]
Selby N.M., et al., “Occurrence of Regional Left Ventricular Dysfunction in Patients Undergoing Standard and Biofeedback Dialysis”, American Journal of Kidney Diseases, 47(5):830-41(2006) abstract. [cited by applicant]
McIntyre C.W., et al., “Biofeedback controlled hemodialysis (BF-HD) reduces symptoms and increases both hemodynamic tolerability and dialysis adequacy in non-hypotension prone stable patients”, Clinical Nephrology, 60(2… [cited by applicant]
Fishbane, S., et al., “Changes to the End-Stage Renal Disease Quality Incentive Program”, Kidney International, 81:1167-1171 (2012). [cited by applicant]
Salman, L., et al., “Interventional Nephrology: Physical Examination as a Tool for Surveillance for the Hemodialysis Arteriovenous Access”, Clin J Am Soc Nephrol 8:1220-1227 (2013). [cited by applicant]
Haussecker, H., & Fleet, D.J., “Estimating Optical Flow with Physical Models of Brightness Variation”, IEEE Conference on Computer Vision and Pattern Recognition, 2:760-767 (2000). [cited by applicant]
Campos, R.P., et al., “Accuracy of Physical Examination and Intra-Access Pressure in the Detection of Stenosis in Hemodialysis Arteriovenous Fistula”, Semin Dial, 21(3):269-273 (2008). [cited by applicant]
Wu, H-Y, et al., “Eulerian Video Magnification for Revealing Subtle Changes in the World”, ACM Transactions on Graphics, 31(4)Article 65:1-8 (2012). [cited by applicant]
Nakajima, K., et al., “ Detection of apparent skin motion using optical flow analysis: Blood pulsation signal obtained from optical flow sequence”, Rev. Sci. Instrum, 68(2):1331-1336 (1997). abstract. [cited by applicant]
Zhu, F., et al., “Estimation of arterio-venous access blood flow in hemodialysis patients using video image processing technique,” 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biolog… [cited by applicant]
Zhu, F., et al., “Assessment of Fistula Flow Using Smartphone Video Analysis”, ASN abstract 2019 (Submission). [cited by applicant]
International Search Report and Written Opinion for International application No. PCT/US2019/051715, mailed on Jan. 2, 2020, 14 pages. [cited by applicant]
Zhu, F., et al., “Continuous Measurement of Calf Resistivity in Hemodialysis Patients using Bioimpedance Analysis,” 2006 International Conference of the IEEE Engineering in Medicine and Biology Society, New York, NY, 20… [cited by applicant]
Dou, Y., et al., “Assessment of extracellular fluid vol. and fluid status in hemodialysis patients: current status and technical advances”, Semin Dial 25(4):377-387 (2012) abstract. [cited by applicant]
Kalantar-Zadeh, K., et al., “Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis”, Circulation 119: 671-679, (2009). [cited by applicant]
Wizemann, V., et al., “The mortality risk of overhydration in haemodialysis patients”, Nephrol Dial Transplant 24:1574-1579 (2009). [cited by applicant]
Xu, Y., et al., “Hypertension, fluid overload and micro inflammation are associated with left ventricular hypertrophy in maintenance hemodialysis patients”, Renal Failure 35(9):1204-1209 (2013). [cited by applicant]
Dekker, MJE, et al., “Impact of fluid status and inflammation and their interaction on survival: a study in an international hemo-dialysis patient cohort,” Kidney Int 91:1214-1223 (2017). [cited by applicant]
Daugirdas, J.T., “Dialysis hypotension: a hemodynamic analysis”, Kidney Int 39(2):233-246 (1991). [cited by applicant]
Van der Sande, F.M., et al., “Intradialytic hypotension—new concepts on an old problem”, Nephrol Dial Transplant 15:1746-1748 (2000). [cited by applicant]
McIntyre, C.W., et al., “Hemodialysis-induced cardiac dysfunction is associated with an acute reduction in global and segmental myocardial blood flow,” Clin J Am Soc Nephrol 3:19-26 (2008). [cited by applicant]
Buchanan, C, et al., “Intradialytic cardiac magnetic resonance imaging to assess cardiovascular responses in a short-term trial of hemodiafiltration and hemodialysis”, J Am Soc Nephrol 28:1269-1277 (2017). [cited by applicant]
Barth, C., et al. Characteristics of hypotension-prone haemodialysis patients: is there a critical relative blood volume? Nephrol Dial Transplant 18:1353-1360 (2003). [cited by applicant]
Steuer, R.R., et al., “Hematocrit as an indicator of blood vol. and predictor of intradialytic morbid events”, ASAIO J 40:M691-M696 (1994). [cited by applicant]
Steuer, R.R., et al., “Reducing symptoms during hemodialysis by continuously monitoring the hematocrit”, Am J Kidney Dis 27(4):525-532 (1996). abstract. [cited by applicant]
Misra, M., et al., “Effect of cause and time of dropout on the residual GFR: a comparative analysis of the decline of GFR on dialysis”, Kidney Int 59:754-763 (2001). [cited by applicant]