Portable hemodialysis machine and disposable cartridge with blood leak sensor

• US 10,172,989 B2
• Filed: 04/07/2015
• Issued: 01/08/2019
• 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): Menon, Krishnan S
• Assistant Examiner(s): Huang, Ryan B
• Application Number:
  US14/680,885
• Publication Number:
  US 20160074568A1
• Time in Patent Office: 1,372 Days
• 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 blood leak sensor assembly, and a processor connected to the various sensors for controlling and monitoring hemodialysis treatment. The blood leak sensor assembly includes a light source for emitting light through the dialysate flow path and a light sensor for receiving light having passed through the dialysate flow path. The processor is connected to the light source for determining whether blood has leaked from the blood flow path into the dialysate flow path. Preferably, the light source emits light having two peak wavelengths.

Claims

1. A hemodialysis system 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 reusable dialysis machine and a disposable cartridge wherein said disposable cartridge is connectable and disconnectable to said reusable dialysis machine, said disposable cartridge having a conduit having a translucent section;

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;

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, said dialysate flow path passing through said conduit'"'"'s translucent section;

a first pump including a first pump motor and a first pump actuator connected to said dialysate flow path upflow from said dialyzer for pumping dialysate through said dialysate flow path to said dialyzer;

a second pump including a second pump motor and a second pump actuator connected to said dialysate flow path downflow from said dialyzer for pumping dialysate through said dialysate flow path;

a third pump including a third pump motor and a third pump actuator connected to said blood flow path for pumping blood through said blood flow path;

a filter connected to said dialysate flow path downflow from said dialyzer for removing uremic toxins from dialysate in said a dialysate flow path after said dialyzer and prior to returning said dialysate to said reservoir;

a blood leak sensor assembly including a light source positioned to transmit light upon said translucent section and a light sensor positioned to receive light from said light source after having passed through said translucent section, said light sensor producing electrical signals representative of the light received by said light sensor; and

a processor connected to said light sensor for processing said light sensor electrical signals for determining whether blood has leaked from said blood flow path into said dialysate flow path;

a first reflector which reflects light from said light source and redirects the light to said conduit'"'"'s translucent section;

a second reflector which receives light from said light source after having passed through said conduit'"'"'s translucent section and redirects the light to said light sensor; and

said light source, said light sensor and said processor are located within said reusable dialysis machine and said first reflector, said second reflector and said conduit'"'"'s translucent section are located within said disposable cartridge, and wherein said light source is positioned to transmit light from said reusable dialysis machine upon said conduit'"'"'s translucent section, and said light sensor is positioned to receive light from said light source after having traveled through said conduit'"'"'s translucent section.

2. The hemodialysis system of claim 1 wherein said light source produces light that has at least two peak wavelengths.

3. The hemodialysis system of claim 1 wherein said light source produces light that has at least two peak wavelengths including a first peak wavelength below 600 nm and a second peak wavelength above 600 nm.

4. The hemodialysis system of claim 1 wherein said light source produces light having at least two peak wavelengths including a first peak wavelength at substantially 570 nm and a second peak wavelength at substantially 660 nm.

5. The hemodialysis system of claim 1, wherein said processor terminates hemodialysis treatment in the event that said processor'"'"'s analysis of said light sensor'"'"'s electrical signals indicates blood in said dialysate flow path.

6. A hemodialysis system of claim 1 wherein:

said first reflector is a first prism which receives light from said light source and redirects said light to said conduit'"'"'s translucent section; and

said second reflector is a second prism which receives light from said light source after having passed through said conduit'"'"'s translucent section and redirects said light to said light sensor.