Portable hemodialysis machine and disposable cartridge

• US 9,801,992 B2
• Filed: 05/09/2017
• Issued: 10/31/2017
• 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:
  US15/590,823
• Publication Number:
  US 20170246368A1
• Time in Patent Office: 175 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 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 including;

a dialyzer;

a blood flow path connected to said arterial blood line and said venous blood line which transports blood from a patient through said dialyzer and back to a patient;

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

a first pump actuator connected to said dialysate flow path upflow from said dialyzer which pumps dialysate through said dialysate flow path;

a second pump actuator connected to said dialysate flow path downflow from said dialyzer which pumps dialysate through said dialysate flow path;

a third pump actuator connected to said blood flow path which pumps blood through said blood flow path;

a flow sensor connected to said dialysate flow path which measures the fluid flow within said dialysate flow path;

a flow sensor connected to said blood flow path which measures the blood flow within said blood flow path;

a pressure sensor connected to said dialysate flow path which measures the pressure within said dialysate flow path;

a pressure sensor connected to said blood flow path which measures the pressure within said blood flow path; and

cartridge electrical terminals electrically connected to said disposable cartridge'"'"'s flow sensors and said disposable cartridge'"'"'s pressure sensors;

said reusable dialysis machine including;

a first pump motor engaging and actuating the operation of said first pump actuator;

a second pump motor engaging and actuating the operation of said second pump actuator;

a third pump motor engaging and actuating the operation of said third pump actuator;

a reservoir for storing a dialysate solution in fluid connection to said a dialysate flow path;

a heater thermally connected to said reservoir which heats fluids in said reservoir;

a temperature sensor which measures the temperature of said fluid;

a level sensor which detects the level of fluid in said reservoir;

a blood leak sensor which detects blood in said dialysate flow path;

a venous blood line pressure sensor connected to said venous blood line which measures pressure in said venous blood line;

a bubble sensor connected to said venous blood line which detects gaseous bubbles in said venous blood line;

a pinch valve connected to said venous blood line which selectively permits or obstructs the flow of blood through said venous blood line;

dialysis machine electrical terminals which electrically connects to said cartridge electrical terminals with said dialysis machine electrical terminals and said cartridge electrical terminals transmitting electrical signals between said reusable dialysis machine and said disposable cartridge; and

a processor connected to said first, second and third pump motors and controls the operation of said pump motors, said processor connected to and monitors said reservoir sensor, said temperature sensor, said blood leak sensor, said venous blood line pressure sensor and said bubble sensor, said processor connected to said dialysis machine electrical terminals to connect to and monitor said disposable cartridge'"'"'s flow sensors and said disposable cartridge'"'"'s pressure sensors, and said processor connected to said pinch valve to control the opening and closing of said pinch valve.

2. The hemodialysis system of claim 1 wherein dialyzer includes a semipermeable membrane that separates said blood flow path and said dialysate flow path and said processor monitors said pressure sensors and controls said pump motors so as to maintain a predetermined pressure differential across said semipermeable membrane.

3. The hemodialysis system of claim 2 wherein said processor maintains said pressure differential within the dialyzer of the blood flow path relative to dialysate flow path at about zero.

4. The hemodialysis system of claim 2 wherein said processor maintains said pressure differential within the dialyzer of the blood flow path relative to dialysate flow path above zero to provide ultrafiltration.

5. The hemodialysis system of claim 1 wherein said pump actuators are constructed of non-deformable components.

6. The hemodialysis system of claim 1 wherein each of said first, second and third pump actuators is constructed of non-deformable components including a housing having a central cavity forming an internal sidewall, a rotor eccentrically positioned within said cavity, and vanes connected to said rotor that seal with the cavity'"'"'s internal sidewall creating vane chambers that pump dialysate through said dialysate flow path.

7. The hemodialysis system of claim 1 wherein said first, second and third pump actuators include sliding vane constructions wherein each pump actuator is constructed of non-deformable components including a housing having a central cavity forming an internal sidewall, a rotor eccentrically positioned within said cavity with said rotor having a plurality of radially aligned slots at said rotor'"'"'s periphery, and vanes slideably positioned in said slots to slide in and out of said slots so as to seal with the cavity'"'"'s internal sidewall creating vane chambers that pump dialysate through said dialysate flow path.