Fresenius Medical Care Holdings, Inc.

Other

Renal Research Institute, LLC

Fresenius Medical Care Deutschland Gmbh

Renaltech International, LLC

Nathan W Levin

Fansan Zhu

Peter Kotanko

Stephan Thijssen

Peter Wabel

Ciro Tetta

Franz Kappel

Len Usvyat

Hans-Dietrich Polaschegg

Vadim Davankov

James A Brady

Benjamin J Lipps

Doris Helene Fuertinger

Norma J Ofsthun

Amanda K Stennett

Frank A Gotch

Daniel Schneditz

Doris Fuertinger

Jochen G Raimann

Erik Lars Penne

Techniques and apparatuses for determining fluid volumes of a patient are described. In one embodiment, for example, an apparatus may include at least one memory, and logic coupled to the at least one memory. The logic may be configured to receive baseline bioimpedance information for at least a portion of a human body at a baseline pressure, receive pressurized bioimpedance information of the portion of the human body at a pressurized pressure, the pressurized pressure greater than the baseline pressure and configured to substantially remove blood volume from the portion at the pressurized pressure, and determine at least one of interstitial fluid volume (V) or peripheral blood volume (BV) based on the baseline bioimpedance information and the pressurized bioimpedance information. Other embodiments are described.

Techniques for determining fluid volumes using bioimpedance information

A peritoneal dialysis (PD) system for infusing a volume of PD solution into a patient's peritoneal cavity in order to perform peritoneal dialysis on the patient includes a peritoneal cavity monitor (PCM) that measures this volume of fluid in the patient's peritoneal cavity by segmental bioimpedance spectroscopy (SBIS), to thereby determine an ultrafiltration volume of fluid in the patient's peritoneal cavity, and a switch, controlled by the PCM, for filling the patient's peritoneal cavity and draining the patient's peritoneal cavity when the ultrafiltration volume is unchanged over time, significantly decreased, or decreasing at a significant rate.

System and method of monitoring and control of ultrafiltration volume during peritoneal dialysis using segmental bioimpedance

Apparatus is disclosed for measuring the circumference of a limb of an individual, e.g., the individual's arm and/or calf. The apparatus uses one or more magnetic strips which surround the limb and contain magnetic coding of length information. Tension is applied to the magnetic strip by a tensioning assembly, which can be a pressure cuff or a stepping motor, and a magnetic read head reads the magnetic coding of length information from the strip. When used in a bioimpedance analysis procedure, the length information can be used to convert measured voltage differences into normalized bioimpedance values, e.g., resistivity values.

Bioimpedance circumference measurement

In an embodiment, the invention relates to methods, apparatus, computer programs and computer program products for estimating a dry weight of a dialysis patient comprising the steps of determining a first fluid status of the patient between treatment sessions in a first stage, determining a second fluid status of the patient during treatment sessions in a second stage and estimating the dry weight based on the second fluid status.

Estimation of the dry weight of a dialysis patient

Methods and apparatus for predicting/estimating the dry weight of an individual, e.g., a patient undergoing dialysis treatment, are provided. The techniques employ a bioimpedance measurement () on the individual's calf () to obtain information regarding the extracellular fluid volume of the calf. Using a measurement of the calf's circumference (), a resistivity value is calculated, normalized by the individual's body mass index (BMI), and then offset by a reference value to obtain a new variable, &#x394;nRho, which is shown, by comparison with a 'gold standard' (FIGS.-), to be highly effective in predicting/estimating dry weight (FIGS.-and-). The techniques are easy to use and provide accurate dry weight predictions/estimations without substantially adding to the complexity or cost of dialysis procedures. The techniques can also be used for individuals who are not renal patients, e.g., patients suffering from other diseases in which fluid overload can occur, athletes, fitness enthusiasts, and the like.

Dry weight predictor

A method of performing regional citrate anticoagulant dialysis of a patient's blood includes flowing blood from and back to the patient through an extracorporeal circuit including a dialyzer having semi-permeable dialysis membranes and a dialysate chamber surrounding the membranes. The method further includes flowing a dialysate containing calcium and citrate through the dialysate chamber of the dialyzer and introducing citrate into the patient's blood upstream of the dialyzer, whereby the patient's blood is dialyzed. The method can further include predicting the concentration of systemic ionized calcium in the blood of the patient at any point in the dialysis treatment or post-dialysis, such as by a mathematical model. The method can further include statistically correcting the preliminary predicted post-dialysis concentration of systemic ionized calcium in the patient's blood to provide a final predicted post-dialysis systemic ionized calcium concentration. The method can further include statistically correcting the preliminary predicted systemic ionized calcium concentration for any time point during the dialysis treatment to provide a final predicted systemic ionized calcium concentration for that time point.

Methods of regional citrate anticoagulation dialysis

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.

System and method of modeling erythropoiesis and its management

The invention is directed to a method of identifying a patient undergoing periodic hemodialysis treatments at increased risk for death that includes determining at least one of the patient's clinical or biochemical parameters, consisting of serum bicarbonate concentration level, serum potassium concentration level, serum calcium concentration level, hemoglobin concentration level, serum phosphorus concentration level, neutrophil to lymphocyte ratio, equilibrated normalized protein catabolic rate (enPCR), equilibrated fractional clearance of total body water by dialysis and residual kidney function (eKdrt/V), EPO resistance index, transferrin saturation index, serum ferritin concentration level, serum creatinine concentration level, platelet count, Aspartat-Aminotransferase level, and Alanin-Aminotransferase level at periodic hemodialysis treatments, and identifying a patient as having an increased risk for death if the patient has a significant change in the rate of change of at least one of the patient's clinical or biochemical parameters. The invention is also directed to a method of identifying an increased mortality risk factor for a patient undergoing periodic hemodialysis treatment. The method includes analyzing data of deceased patients that were previously undergoing periodic hemodialysis treatments by performing a longitudinal analysis backwards in time of changes in a clinical or biochemical parameter the patients, and identifying a significant change in the rate of decline or the rate of increase in a clinical or biochemical parameter before death of the patients.

Method of identifying when a patient undergoing hemodialysis is at increased risk of death

A method of detecting an indication of a potential intradialytic morbid event (IME) by monitoring a patient's condition during excess fluid removal by ultrafiltration during a hemodialysis treatment includes determining the patient's relative blood volume (RBV), and removing a portion of the volume of excess fluid from blood of the patient at an initial ultrafiltration rate while periodically monitoring a second derivative over time of the relative blood volume (SDRBV). The method then includes continuing to remove excess fluid from blood of the patient at the same ultrafilration rate, or, optionally, incrementally increasing the ultrafiltration rate. The method further includes triggering an alarm for an IME for the patient if the SDRBV is in a range of between a low SDRBV alarm level and a high SDRBV alarm level, and, alternatively or additionally monitoring the patient's normalized blood pressure ratio, and taking a remedial action if the alarm is triggered.

Detecting indications of intradialytic morbid events by measurement of relative blood volume, blood pressure and heart rate

The invention is directed to a method of identifying a patient undergoing periodic hemodialysis treatments at increased risk for death that includes determining at least one of the patient's clinical or biochemical parameters, including systolic blood pressure, serum albumin concentration level, body weight, body temperature, serum bicarbonate concentration level, serum potassium concentration level, serum calcium concentration level, hemoglobin concentration level, serum phosphorus concentration level, neutrophil to lymphocyte ratio, equilibrated normalized protein catabolic rate (enPCR), equilibrated fractional clearance of total body water by dialysis and residual kidney function (eKdrt/V), EPO resistance index, transferrin saturation index, serum ferritin concentration level, serum creatinine concentration level, platelet count, Aspartat-Aminotransferase level, and Alanin-Aminotransferase level at periodic hemodialysis treatments, and identifying a patient as having an increased risk for death if the patient has a significant change in the rate of change of at least one of the patient's clinical or biochemical parameters. The invention is also directed to a method of identifying an increased mortality risk factor for a patient undergoing periodic hemodialysis treatment. The method includes analyzing data of deceased patients that were previously undergoing periodic hemodialysis treatments by performing a longitudinal analysis backwards in time of changes in a clinical or biochemical parameter the patients, and identifying a significant change in the rate of decline or the rate of increase in a clinical or biochemical parameter before death of the patients.

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, the model including iron homeostasis, and 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. 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 hemodialysis system.

System and method of modeling erythropoiesis including iron homeostasis

The invention is directed to a method of determining a dosage of phosphorus binder for a patient undergoing dialysis treatment to achieve a pre-dialysis serum phosphorus concentration within a desired concentration range while achieving a desired net accumulation of calcium. The method includes determining the dosage of phosphorus binder that will achieve pre-dialysis serum phosphorus concentration of the patient that is within the desired concentration range while accounting for the change in the amount of phosphorus removed by the dialysis treatment when the pre-dialysis serum phosphorus concentration of the patient is within the desired concentration range, determining a dialysate calcium concentration that will result in the desired net accumulation of calcium over a complete dialysis cycle, and dialyzing the patient with a dialysate containing a calcium concentration based upon that determination.

Growing community of inventors

New York, NY, United States of America

Nathan W Levin