Portable hemodialysis machine and disposable cartridge with dialysis reservoir level sensor

• US 9,649,419 B2
• Filed: 06/29/2015
• Issued: 05/16/2017
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Diality, Inc.
• Original Assignee: EasyDial, Inc.
• Inventors: Giordano, Renato, Corder, Rodney
• Primary Examiner(s): Clemente, Robert
• Assistant Examiner(s): VARMA, AKASH K
• Application Number:
  US14/753,982
• Publication Number:
  US 20160074566A1
• Time in Patent Office: 687 Days
• Field of Search: 210 86
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/1645 with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 : Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362264 : the filter being a blood filter
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3661 : for haemodialysis
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/127 : with provisions for heating or cooling
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/27 : preventing use
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3327 : Measuring
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 : Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3653 : by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/75 : with filters

Abstract

A portable hemodialysis system is provided including a disposable cartridge and a reused dialysis machine. The disposable cartridge includes a dialysate flow path and a blood flow path which flow in opposite directions through a dialyzer. The disposable cartridge includes a filter for removing waste products from the dialysate. The reused dialysis machine possesses a reservoir for dialysate, various sensors including a reservoir level sensor assembly, and a processor connected to the various sensors for controlling and monitoring hemodialysis treatment. The reservoir level sensor assembly includes a vertically extending electrode array for transmitting electrical signals to the processor detecting whether the reservoir possesses sufficient dialysate for therapy, and for detecting whether there is a fault condition during therapy such as a loss of dialysate in the reservoir or an increase in fluid in the reservoir which may indicate a failure in the dialysis membrane.

Claims

1. A hemodialysis system with reservoir level sensor comprising:

an arterial blood line for connecting to a patient'"'"'s artery for collecting blood from a patient;

a venous blood line for connecting to a patient'"'"'s vein for returning blood to a patient;

a dialyzer;

a blood flow path connected to said arterial blood line and said venous blood line for transporting blood from a patient to said dialyzer and back to a patient;

a reservoir for storing a dialysate solution, said reservoir including a nominal fill level below the top of said reservoir;

a dialysate flow path, isolated from the blood flow path, for transporting a dialysate from said reservoir to said dialyzer and back to said reservoir;

a first pump for pumping dialysate through said dialysate flow path;

a second pump for pumping blood through said blood flow path;

a filter connected to said dialysate flow path for removing uremic toxins from dialysate;

a reservoir level sensor within said reservoir for measuring the level of dialysate in said reservoir, said reservoir level sensor including at least three electrodes and a ground path, said three electrodes positioned vertically in said reservoir to form an electrode array including a top electrode, a first middle electrode and a bottom electrode wherein said top electrode is positioned above said nominal fill level and said first middle electrode and said bottom electrode are positioned below said nominal fill level, and each electrode produces level sensor electrical signals reflecting the capacitance of fluid within said reservoir; and

a processor connected to said reservoir level sensor for processing said level sensor electrical signals for determining the level of dialysate in said reservoir, said processor analyzing the level sensor electrical signals from said top electrode for determining a reference value for ambient capacitance coupling and said processor analyzing the level sensor electrical signals from said bottom electrode to determining a reference value for the capacitance coupling of fluid in said reservoir, said processor analyzing the level sensor signals from said first middle electrode for determining the level of dialysate in said reservoir, and said processor disables said hemodialysis system if said level sensor detects the level of dialysate in said reservoir is below a predetermined threshold.

2. The hemodialysis system with reservoir level sensor of claim 1 wherein said level sensor includes eight electrodes aligned vertically in said reservoir to form an electrode array having four electrodes including a top electrode and three middle electrodes positioned above said nominal fill level, and a bottom electrode and three middle electrodes positioned below said nominal fill level, and wherein each electrode produces level sensor electrical signals reflecting the capacitance of fluid within said reservoir.

3. The hemodialysis system with reservoir level sensor of claim 1 further comprising:

a reusable dialysis machine and a disposable cartridge wherein said disposable cartridge is connectable and disconnectable to said reusable dialysis machine; and

said reservoir and said reservoir level sensor are positioned within said reusable dialysis machine.

4. The hemodialysis system with reservoir level sensor of claim 3 wherein said level sensor includes eight electrodes aligned vertically in said reservoir to form an electrode array having four electrodes including a top electrode and three middle electrodes positioned above said nominal fill level, and a bottom electrode and three middle electrodes positioned below said nominal fill level, and wherein each electrode produces level sensor electrical signals reflecting the capacitance of fluid within said reservoir.