Portable hemodialysis machine and disposable cartridge with flow sensor

• US 9,649,420 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:
  US14/754,059
• Publication Number:
  US 20160074565A1
• Time in Patent Office: 687 Days
• Field of Search: 210 85, 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 further includes a filter for removing waste products from the dialysate as well as one or more flow sensors for measuring the flow of dialysate in the dialysate flow path. The preferred flow sensor includes a rotatable spoked wheel in the dialysate flow path which is rotated by the flow of dialysate. The spoked wheel includes one or more magnets which are rotated with the rotation of the spoked wheel. The flow sensor further includes a magnetic field sensor in the reused dialysis machine which is connected to a processor for monitoring the rotation of the spoked wheel to determine flow of fluid in the dialysate flow path.

Claims

1. A hemodialysis system with dialysate flow 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 reusable dialysis machine and a disposable cartridge wherein said disposable cartridge is connectable and disconnectable to said reusable dialysis machine;

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 flow sensor including a rotatable spoked wheel in said dialysate flow path and rotating with the flow of dialysate in said dialysate flow path, said spoked wheel including one or more magnets, and said flow sensor including a magnetic field sensor adjacent to said one or more magnets for detecting the rotation of said spoked wheel; and

a processor connected to said flow sensor'"'"'s magnetic field sensor for monitoring the rotation of said spoked wheel for determining the flow rate of dialysis through said dialysate flow path;

and wherein said processor and magnetic field sensor are located within said reusable dialysis machine, and said spoked wheel is located within said disposable cartridge.

2. The hemodialysis system with flow sensor of claim 1 wherein said magnetic field sensor is a hall effect sensor.

3. A hemodialysis system with dialysate flow 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 reusable dialysis machine and a disposable cartridge wherein said disposable cartridge is connectable and disconnectable to said reusable dialysis machine;

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 first flow sensor including a first rotatable spoked wheel in said dialysate flow path upflow of said dialyzer, said first spoked wheel rotating with the flow of dialysate in said dialysate flow path, said first spoked wheel including one or more magnets, and said first flow sensor including a first magnetic field sensor adjacent to said one or more magnets for detecting the rotation of said first spoked wheel;

a second flow sensor including a second rotatable spoked wheel in said dialysate flow path downflow flow of said dialyzer, said second spoked wheel rotating with the flow of dialysate in said dialysate flow path, said second spoked wheel including one or more magnets, and said second flow sensor including a second magnetic field sensor adjacent to said one or more magnets for detecting the rotation of said second spoked wheel; and

a processor connected to said first and second magnetic field sensors for monitoring the rotation of said first and second spoked wheels for determining the flow rate of dialysis through said dialysate flow path;

and wherein said processor and first and second magnetic field sensors are located within said reusable dialysis machine, and said first and second spoked wheels are located within said disposable cartridge.

4. The hemodialysis system with flow sensor of claim 3 wherein said magnetic field sensors are hall effect sensors.

5. The hemodialysis system with flow sensor of claim 3 wherein said processor compares the rotation of the first spoked wheel to the rotation of the second spoked wheel to determine if the dialysate is flowing properly through the dialysate flow path.