Status assessment of an individual undergoing peritoneal dialysis

Patent metadata

Field	Value
Publication number	US-2023347034-A1
Application number	US-202118024445-A
Country	US
Kind code	A1
Filing date	Sep 2, 2021
Priority date	Sep 4, 2020
Publication date	Nov 2, 2023
Grant date	—

Abstract

A test method determines at least one status parameter of an individual undergoing peritoneal dialysis. The status parameter(s) may include a transport property of the peritoneum, a tonicity, or a residual volume. The test method includes receiving first data indicative of a flow rate as a function of time of a treatment fluid into and out of a peritoneal cavity during a test procedure, and second data comprising measured data samples representing a concentration of one or more solutes in the treatment fluid at time points during the test procedure. The test method also includes computing, based on the first data and by use of a transport model for a peritoneal membrane, estimated data samples representing the concentration of the one or more solutes in the treatment fluid at the time points and determining the status parameter(s) as a function of the measured data samples and the estimated data samples.

First claim

1 - 47 . (canceled)

48 . An arrangement for determining at least one status parameter of an individual undergoing peritoneal dialysis, the arrangement comprising:
an input for receiving:
first data indicative of a flow rate as a function of time of a treatment fluid into and out of a peritoneal cavity, via a peritoneal cavity access of the individual, during one or more fluid exchange cycles, wherein each fluid exchange cycle comprises a fill phase, a dwell phase, and a drain phase, and
second data comprising measured data samples representing a concentration of one or more solutes in the treatment fluid in the peritoneal cavity at two or more time points during the one or more fluid exchange cycles;
a first computation module configured to compute, based on the first data and by use of a mathematical model of a transport of water and solutes through a peritoneal membrane in the peritoneal cavity, estimated data samples representing the concentration of the one or more solutes in the treatment fluid in the peritoneal cavity at the two or more time points; and a second computation module configured to determine the at least one status parameter as a function of the measured data samples and the estimated data samples.

49 . The arrangement of claim 48 , wherein the at least one status parameter comprises a transport property of the peritoneal membrane.

50 . The arrangement of claim 48 , wherein the second computation module comprises a parameter fitting algorithm and is operable to determine, by use of the parameter fitting algorithm, a respective candidate value of a set of parameters included in the mathematical model to minimize one or more differences between the measured and estimated data samples, wherein the set of parameters comprises the at least one status parameter.

51 . The arrangement of claim 50 , wherein the first computation module is further configured to compute, as a function of the measured and estimated data samples, a measured temporal change and an estimated temporal change in conductivity during the drain phase of the one or more fluid exchange cycles, and wherein the second computation module is operable to determine, by use of the parameter fitting algorithm, the respective candidate value to further minimize a difference between the measured temporal change and the estimated temporal change.

52 . The arrangement of claim 50 , wherein the set of parameters represents a diffusion capacity of one or more solutes through the peritoneal membrane and a filtration capacity of water through the peritoneal membrane.

53 . The arrangement of claim 50 , wherein the set of parameters further represents a tonicity of the individual.

54 . The arrangement of claim 50 , wherein the first computation module is configured to repeatedly compute the estimated data samples based on the respective candidate value of the set of parameter values determined by the second computation module, and the second computation module is configured to repeatedly determine the respective candidate value of the set of parameters based on the estimated data samples from the first computation module, wherein the second computation module is configured to output the at least one status parameter when a convergence criterion is fulfilled or a time limit is reached.

55 . The arrangement of claim 48 , wherein the first computation module is further configured to compute, based on the first data and by use of the mathematical model, a time sequence of estimated amounts of the treatment fluid in the peritoneal cavity for a time period during the one or more fluid exchange cycles.

56 . The arrangement of claim 48 , which is further configured to evaluate the at least one status parameter for detection of a potential failure of the peritoneal membrane and, upon detection of the potential failure, generate an alarm or an alert.

57 . The arrangement of claim 48 , wherein the first computation module comprises a differential equation solver sub-module configured to calculate, from an initial time point to an end time point, an amount of the treatment fluid in the peritoneal cavity from the initial time point to the end time point including intermediate time steps, and to calculate the concentration of one or more solutes in the treatment fluid in the peritoneal cavity from the initial time point to the end time point including the intermediate time steps.

58 . The arrangement of claim 48 , wherein the one or more fluid exchange cycles comprises two consecutive exchange cycles, wherein the two or more time points comprise a time point during the drain phase of a first fluid exchange cycle, and a time point during the dwell phase of a second fluid exchange cycle following upon the first exchange cycle.

59 . The arrangement of claim 48 , wherein the input is further arranged to receive fluid exchange data for the individual in a preceding time period before the one or more fluid exchange cycles, wherein the arrangement is further configured to estimate, based on the fluid exchange data, an initial concentration of one or more solutes in the treatment fluid in the peritoneal cavity at an evaluation starting point, and wherein the first computation module is configured to compute the estimated data samples based on the initial concentration.

60 . The arrangement of claim 48 , wherein the at least one status parameter comprises a volume of treatment fluid in the peritoneal cavity at a selected time point.

61 . The arrangement of claim 60 , wherein the measured data samples in the second data comprise a first data sample taken during a drain phase and a second data sample taken after completion of a fill phase subsequent to the drain phase, and wherein the second computation module is configured to determine the volume of treatment fluid in the peritoneal cavity at the selected time point.

62 . The arrangement of claim 61 , wherein the first and second data samples are taken during an initial probing cycle which comprises the drain phase and the fill phase and in which a restricted amount of the treatment fluid in the peritoneal cavity is extracted in the drain phase, the restricted amount corresponding to a fraction of a maximum fill volume of the peritoneal cavity.

63 . The arrangement of claim 62 , which is configured to provide output data representing the volume of treatment fluid in the peritoneal cavity, for receipt by a peritoneal dialysis arrangement that is operated to perform the peritoneal dialysis, such that the peritoneal dialysis arrangement is caused to initiate a drain phase after the initial probing cycle when the volume of the treatment fluid is above a limit value, and to initiate a fill phase after the initial probing cycle when the volume of treatment fluid is below the limit value.

64 . The arrangement of claim 48 , wherein the at least one status parameter comprises a tonicity parameter of the individual.

65 . A peritoneal dialysis arrangement, comprising:
an extracorporeal fluid circuit that is connectable to a peritoneal access of an individual for conveying treatment fluid from/to a peritoneal cavity; at least one sensor device, which is arranged in the extracorporeal fluid circuit and configured to provide data samples representative of a concentration of one or more solutes in the treatment fluid; a control apparatus configured to operate the extracorporeal fluid circuit and obtain the data samples from the sensor device; and an arrangement in accordance with claim 1 , which is connected to receive the first and second data from

Assignees

• Gambro Lundia Ab

Inventors

• Borgqvist Per-Olof
• Öberg Carl
• Bergling Karin

Classifications

• A61M1/282 Primary

  Operational modes · CPC title

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title

• G16H20/40 Primary

  relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture · CPC title

• A61M1/154

  with sensing means or components thereof · CPC title

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title