Portable hemodialysis machine and disposable cartridge

• US 9,364,599 B2
• Filed: 02/26/2015
• Issued: 06/14/2016
• Est. Priority Date: 02/27/2014
• Status: Active Grant

• Current Assignee: Diality, Inc.
• Original Assignee: EasyDial, Inc.
• Inventors: Giordano, Renato, Corder, Rodney
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US14/632,163
• Publication Number:
  US 20150238676A1
• Time in Patent Office: 474 Days
• US Class Current: 1/1
• 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 1/1621 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 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/121 interface between cassette and base
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• 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 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/441 : generated by an electromotor
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61M 60/849 : Disposable parts
• CPC Class Codes: A61M 60/853 : the valve being formed by a flexible tube element which is clamped for restricting the flow

Abstract

A portable hemodialysis system is provided including a disposable cartridge and a reused dialysis machine. The disposable cartridge includes a dialyzer, and a dialysate flow path and a blood flow path which flow in opposing directions through the dialyzer. The disposable cartridge includes a filter for removing waste products from the dialysate, and pressure and fluid flow sensors for measuring the pressure and fluid flow in the dialysate flow path and blood flow path. In addition, the disposable cartridge possesses pump actuators (but not pump motors) for pumping dialysate and blood through their respective flow paths. The reused dialysis machine possesses a reservoir for dialysate, a level sensor, a blood leak sensor, an ammonia sensor, a venous blood line pressure sensor, a venous blood line bubble detector, pump motors, and a processor connected to the motors and sensors for controlling and monitoring hemodialysis treatment.

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 for transporting blood from a patient through said dialyzer and back to a patient;

a dialysate flow path, isolated from the blood flow path, for transporting 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 for pumping dialysate through said dialysate flow path;

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 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 said a dialysate flow path, said filter positioned within a housing having a vapor membrane which permits ammonia to pass through said vapor membrane but not dialysate liquid;

a first flow sensor connected to said dialysate flow path upflow from said dialyzer for detecting the fluid flow within said dialysate flow path;

a second flow sensor connected to said dialysate flow path downflow from said dialyzer for detecting the fluid flow within said dialysate flow path;

a third flow sensor connected to said blood flow path upflow from said dialyzer for detecting the blood flow within said blood flow path;

a fourth flow sensor connected to said blood flow path downflow from said dialyzer for detecting the fluid flow within said blood flow path;

a first pressure sensor connected to said dialysate flow path upflow from said dialyzer for detecting the pressure within said dialysate flow path;

a second pressure sensor connected to said dialysate flow path downflow from said dialyzer for detecting the pressure within said dialysate flow path;

a third pressure sensor connected to said blood flow path upflow from said dialyzer for detecting the pressure within said blood flow path;

a fourth pressure sensor connected to said blood flow path down flow from said dialyzer for detecting the pressure within said blood flow path; and

cartridge electrical terminals electrically connected to said disposable cartridge'"'"'s first, second, third and fourth flow sensors and said disposable cartridge'"'"'s first, second, third, and fourth 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 for heating fluids in said reservoir;

a temperature sensor for measuring the temperature of said fluid;

a level sensor for detecting the level of fluid in said reservoir;

a blood leak sensor for detecting blood in said dialysate flow path;

an ammonia sensor adjacent to said vapor membrane for sensing ammonia released from said filter;

a venous blood line pressure sensor connected to said venous blood line for sensing pressure in said venous blood line;

a bubble sensor connected to said venous blood line for detecting gaseous bubbles in said venous blood line;

a pinch valve connected to said venous blood line for selectively permitting or obstructing the flow of blood through said venous blood line;

dialysis machine electrical terminals for electrically connecting to said cartridge electrical terminals for transmitting electrical signals between said reusable dialysis machine and said disposable cartridge; and

a processor connected to said first, second and third pump motors for controlling operation of said pump motors, said processor connected to said reservoir sensor, said temperature sensor, said blood leak sensor, said ammonia sensor, said venous blood line pressure sensor, and said bubble sensor for monitoring said dialysis machine sensors, 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 for controlling 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 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.