Hemodialysis systems and methods

• US 9,302,037 B2
• Filed: 08/19/2013
• Issued: 04/05/2016
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Wilt, Michael J., Demers, Jason A., Grant, Kevin L., Tracey, Brian D., Dale, James D.
• Primary Examiner(s): Kim, John
• Application Number:
  US13/969,947
• Publication Number:
  US 20140102970A1
• Time in Patent Office: 960 Days
• Field of Search: 210/175, 210/252, 210/257.2, 210/258, 210/321.6, 422/50, 422/547, 422/552, 422/565, 422/117
• US Class Current: 1/1
• 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 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• 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 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3424 Substitution fluid path
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362263 : Details of incorporated filters
• CPC Class Codes: A61M 1/362265 : Details of valves
• CPC Class Codes: A61M 1/362266 : Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3623 : Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3638 : with a vapour trap
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3652 : using gas, e.g. air
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/07 : having air pumping means
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• 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 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/82 : Internal energy supply devices
• CPC Class Codes: A61M 2205/8218 : Gas operated
• CPC Class Codes: A61M 2205/8225 : using incorporated gas cartridges for the driving gas
• CPC Class Codes: Y10T 137/87893 : With fluid actuator

Abstract

Disclosed are hemodialysis and similar dialysis systems including fluid flow circuits. Hemodialysis systems may include a blood flow path, and a dialysate flow path including balancing, mixing, and/or directing circuits. Preparation of dialysate may be decoupled from patient dialysis. Circuits may be defined within one or more cassettes. The fluid circuit and/or the various fluid flow paths may be isolated from electrical components. Fluid circuits and electrical components may be contained in a housing comprising a first section separated from a second section by a thermally insulating barrier. The first section may house a heater and heat-sterilizable components including liquid flowpaths, pumps or valves, while the second section houses electronic components for controlling the hemodialysis system. The insulating barrier may be configured to inhibit the second section from being exposed to sterilizing temperatures produced in the first section.

Claims

1. A hemodialysis system comprising:

a housing comprising a first section separated from a second section by a thermally insulating barrier;

the first section housing a heater and heat-sterilizable components including liquid flowpaths, pumps or valves;

the second section housing electronic components for controlling the hemodialysis system, wherein

the insulating barrier is configured to inhibit the second section from being exposed to sterilizing temperatures produced in the first section.

2. The hemodialysis system of claim 1, wherein the first section is closed to the external environment when the liquid flowpaths, pumps or valves are undergoing heat sterilization.

3. The hemodialysis system of claim 1, wherein the second section is open to the external environment when the liquid flowpaths, pumps or valves are undergoing heat sterilization.

4. The hemodialysis system of claim 1, wherein the second section includes a manifold, and the first section includes a plurality of control fluid lines for controlling a plurality of pumps or valves in the first section.

5. The hemodialysis system of claim 4, wherein the manifold is a pneumatic manifold, and the control fluid lines are configured to carry air under positive or negative pressure.

6. The hemodialysis system of claim 5, wherein the control fluid lines are connected on one end to the pumps or valves, and are connected on an opposing end to a tube-support housing, the tube support housing configured to reversibly connect the plurality of control fluid lines to a mating receptacle fluidically connected across the insulating barrier with the pneumatic manifold.

7. The hemodialysis system of claim 1, wherein the heater is configured to heat liquid in the liquid flowpaths, pumps or valves to a temperature of at least about 80 degrees C., while the temperature in the first section is prevented from exceeding about 60 degrees C.

8. The hemodialysis system of claim 3, wherein the second section includes a fan or grid to circulate air between the second section and the external environment.

9. The hemodialysis system of claim 1, wherein the second section includes an electronic controller, a power supply, or a pneumatic manifold.

10. The hemodialysis system of claim 1, wherein the first section includes a liquid pumping cassette, one or more temperature sensors, one or more conductivity sensors, or a blood leak sensor.

11. The hemodialysis system of claim 10, wherein the first section includes the liquid pumping cassette, and wherein the liquid pumping cassette comprises a plurality of membrane-based pumps, membrane-based valves, liquid flow paths, liquid inlets, liquid outlets, and control fluid ports.

12. The hemodialysis system of claim 11, further comprising a sensor manifold, the sensor manifold comprising a plurality of liquid conduits, each liquid conduit including a temperature or conductivity sensor, wherein the liquid conduits are configured to fluidically connect with a plurality of liquid flow paths in the pumping cassette.

13. The hemodialysis system of claim 12, wherein one or more liquid conduits of the sensor manifold comprises an air trap.

14. The hemodialysis system of claim 1, wherein the insulating barrier comprises an insulating wall comprising insulation.

15. The hemodialysis system of claim 14, wherein the insulation comprises molded foam insulation, spray insulation, or an insulation cut from sheets.

16. The hemodialysis system of claim 1, wherein the first section is encased in or completely surrounded by insulation, which forms the insulating barrier.