Dialysis and methods including sensor feedback to improve patient experience

Patent metadata

Field	Value
Publication number	US-2020030517-A1
Application number	US-201916522229-A
Country	US
Kind code	A1
Filing date	Jul 25, 2019
Priority date	Jul 26, 2018
Publication date	Jan 30, 2020
Grant date	—

Abstract

Peritoneal dialysis, such as automated peritoneal dialysis (“APD”) is provided with any one or more or all of the following sensing or feedback features: impedance sensing to detect peritonitis, temperature sensing to detect peritonitis, bio-MEMS sensing to detect peritonitis, and glucose control for diabetes patients, wherein each sensing or feedback feature analyzes patient effluent fluid or fluid dwelling within a patient's peritoneal cavity.

First claim

The invention is claimed as follows:

1 . A peritoneal dialysis (“PD”) system comprising:
a cycler including a pump actuator and a control unit in operable communication with the pump actuator;
a disposable set including a disposable cassette having a pump chamber, the disposable cassette sized and arranged to be held by the cycler such that the pump chamber is in operable communication with the pump actuator, the disposable set including a patient line and a drain line extending from the disposable cassette;
a catheter for placement within a patient's peritoneal cavity and for fluid communication with the patient line; and
an impedance sensor operably coupled to one of the catheter, patient line, or drain line to sense an impedance of PD fluid residing within the patient, or removed from the patient, the sensed impedance used to detect white blood cells to form a patient peritonitis determination, the control unit configured to communicate the peritonitis determination.

2 . The PD system of claim 1 , wherein the sensed impedance is sent to the control unit, and wherein the control unit is configured to analyze the sensed impedance.

3 . The PD system of claim 2 , wherein the sensed impedance is sent to the control unit wired or wirelessly.

4 . The PD system of claim 1 , which includes a network and at least one doctor or clinician computer in communication with the control unit via the network, the control unit configured to communicate the peritonitis determination to at least one of a patient or caregiver via a user interface of the cycler or the at least one doctor or clinician computer via the network.

5 . The PD system of claim 1 , which includes a water purifier configured to supply purified water to the disposable set, the water purifier including a water purifier control unit, wherein the sensed impedance is sent to the water purifier control unit, wherein the water purifier control unit is configured to analyze the sensed impedance, and wherein the cycler control unit and the water purifier control unit are in communication to allow the cycler control unit to communicate the peritonitis determination.

6 . The PD system of claim 1 , wherein the impedance sensor is located within a connector configured to couple to the catheter, the patient line or the drain line.

7 . The PD system of claim 6 , wherein the connector is (i) a clamshell connector that fits around the catheter, the patient line or the drain line or (ii) configured to be spliced between two sections of the catheter, the patient line or the drain line.

8 . The PD system of claim 6 , wherein the impedance sensor includes electrodes positioned and arranged within the catheter, the patient line or the drain line, the connector positioned over the electrodes.

9 . The PD system of claim 8 , wherein the connector includes leads extending from the electrodes to (i) the control unit, (ii) a control unit of a water purifier configured to supply purified water to the disposable set, or (iii) a wireless module provided with the connector.

10 . The PD system of claim 1 , which is configured to analyze the sensed impedance of the PD fluid residing within the patient, or removed from the patient, via a frequency sweep that moves from a start frequency to a stop frequency.

11 . The PD system of claim 10 , wherein the frequency sweep is generated by a frequency generator provided by or operable with the control unit.

12 . The PD system of claim 10 , which is configured to take an impedance measurement at two or more frequencies of the frequency sweep.

13 . The PD system of claim 10 , wherein the frequency sweep enables fluid having white blood cells and residing within the patient, or removed from the patient, to be determined by measuring, over at least a portion of the frequency sweep, higher impedances for the fluid having white blood cells than impedances for fluid not having white blood cells.

14 . The PD system of claim 13 , wherein the measured impedances for fluid not having white blood cells (i) are determined based on set standard impedances or (ii) are determined based on impedances established for the patient.

15 . The PD system of claim 10 , wherein the frequency sweep enables fluid having white blood cells and residing within the patient, or removed from the patient, to be distinguished from fluid having fibrin, wherein the fluid having fibrin yields higher impedances over at least a portion of the sweep than the fluid having white blood cells.

16 . The PD system of claim 1 , wherein the peritonitis determination is a first peritonitis indicator, and which includes at least one different peritonitis indicator useable in combination with the first peritonitis indicator to form an overall peritonitis determination.

17 . The PD system of claim 16 , wherein the at least one different peritonitis indicator useable in combination with the first peritonitis indicator is obtained from at least one of a patient effluent PD fluid temperature sensor or a white blood cell biosensor.

18 . The PD system of claim 1 , wherein the peritonitis determination is provided in combination with insulin injection made using feedback from a patient effluent glucose biosensor.

19 . A peritoneal dialysis (“PD”) system comprising:
a cycler including a pump actuator and a control unit in operable communication with the pump actuator;
a disposable set including a pump portion sized and arranged to be held by the cycler such that the pump portion is in operable communication with the pump actuator, the disposable set including a patient line and a drain line extending from the disposable cassette;
a catheter for placement within a patient's peritoneal cavity and for fluid communication with the patient line; and
an impedance sensor operably coupled to one of the catheter, patient line, or drain line to sense an impedance of PD fluid residing within the patient, or removed from the patient, the sensed impedance used to detect white blood cells to form a patient peritonitis determination.

20 . A peritoneal dialysis (“PD”) system comprising:
a pump actuator and a control unit in operable communication with the pump actuator;
a disposable set including a pump portion sized and arranged to be placed in operable communication with the pump actuator, the disposable set including a patient line and a drain line extending from the disposable cassette;
a catheter for placement within a patient's peritoneal cavity and for fluid communication with the patient line; and
an impedance sensor operably coupled to one of the catheter, patient line, or drain line to sense PD fluid residing within the patient, or removed from the patient, over a frequency sweep that moves from a start frequency to a stop frequency, the sensed impedance frequency sweep used to detect white blood cells to form a patient peritonitis determination.

Assignees

• Baxter Int
• Baxter Healthcare Sa

Inventors

• Basati Sukhraaj
• Gadre Shantanu Avinash
• Jamnia Mohammad Ali
• Nair Lakshmy M
• O'Reilly William J
• Wlodarczyk Marta

Classifications

• A61B5/14507

  specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045) · CPC title

• A61M2205/3317

  Electromagnetic, inductive or dielectric measuring means · CPC title

• A61M1/28 Primary

  Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation} · CPC title

• A61B5/0538

  invasively, e.g. using a catheter · CPC title

• A61M2230/65

  Impedance, e.g. conductivity, capacity · CPC title