Portable hemodialysis machine and disposable cartridge

• US 10,625,008 B2
• Filed: 12/18/2018
• Issued: 04/21/2020
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Diality, Inc.
• Original Assignee: Diality, Inc.
• Inventors: Giordano, Renato, Corder, Rodney
• Primary Examiner(s): Clemente, Robert
• Assistant Examiner(s): Varma, Akash K
• Application Number:
  US16/223,686
• Publication Number:
  US 20190117866A1
• Time in Patent Office: 490 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 dialyzer, and a dialysate flow path and a blood flow path which flow in opposing directions through the dialyzer. The disposable cartridge includes 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. Preferably, the disposable cartridge includes a filter for removing waste products from dialysate.

Claims

1. A disposable cartridge for hemodialysis comprising:

a blood flow path;

a dialysate flow path, isolated from the blood flow path;

a dialyzer in said blood flow path and said dialysate flow path, said dialyzer including a semipermeable membrane that separates said blood flow path and said dialysate flow path;

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; and

a conduit having a translucent section wherein said dialysate flow path passes through said translucent section, and wherein said translucent section is positioned at the exterior of the disposable cartridge so as to be able to engage an optical blood sensor.

2. The disposable cartridge for hemodialysis of claim 1 further comprising:

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

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

cartridge electrical terminals electrically connected to said disposable cartridge'"'"'s flow sensor and said disposable cartridge'"'"'s pressure sensor, said cartridge electrical terminals located upon the exterior of the disposable cartridge so as to engage and electrically connect, or disengage and electrically disconnect, to electrical terminals of a reusable dialysis machine.

3. The disposable cartridge for hemodialysis of claim 1 further comprising a filter which removes waste products from dialysate.

4. The disposable cartridge for hemodialysis of claim 1 wherein said pump actuators are constructed of non-deformable components.

5. The disposable cartridge for hemodialysis of claim 1 wherein each of said first and second 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.

6. The disposable cartridge for hemodialysis of claim 1 wherein said first and second 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.

7. The disposable cartridge for hemodialysis of claim 2 wherein said flow sensor includes a rotatable spoked wheel in said dialysate flow path which rotates with the flow of dialysate in said dialysate flow path.

8. The disposable cartridge for hemodialysis of claim 2 wherein said flow sensor includes a rotatable spoked wheel in said dialysate flow path which rotates with the flow of dialysate in said dialysate flow path, said spoked wheel including one or more magnets.