Hemodialysis system including on-line dialysate generation

• US 8,894,600 B2
• Filed: 09/17/2010
• Issued: 11/25/2014
• Est. Priority Date: 11/05/2003
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Kelly, Thomas, Childers, Robert W., Busby, Don, Roger, Rodolfo, El Sayyid, Waleed Mutasem, Din, Shahid
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/884,972
• Publication Number:
  US 20110105983A1
• Time in Patent Office: 1,530 Days
• Field of Search: 604 401- 616, 422 44- 48, 210644-647
• US Class Current: 604/6.1
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• 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 1/1563 Details of incorporated filters
• 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 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• 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 1/1629 with integral heat exchanger
• CPC Class Codes: A61M 1/1633 with more than one dialyser unit
• CPC Class Codes: A61M 1/1635 with volume chamber balancing devices between used and fresh dialysis fluid
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• 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 1/288 : Priming priming in extracorporeal blood circuits A61M1/3643
• 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 1/3417 : using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/342 : Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3427 : back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3431 : upstream of the filter
• CPC Class Codes: A61M 1/3434 : with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 : downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3444 : in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/3451 : the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/3458 : having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3465 : using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3468 : using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3472 : with treatment of the filtrate
• CPC Class Codes: A61M 1/3486 : Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362223 : the interface being evacuated interfaces to enhance contact
• 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 1/362265 : Details of valves
• CPC Class Codes: A61M 1/3624 : Level detectors; Level control
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• 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 1/3647 : with recirculation of the priming solution
• 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 1/3656 : Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2202/0413 : Blood
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/127 : with provisions for heating or cooling
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/276 : preventing unwanted use
• 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 2205/3327 : Measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 : Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• 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 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/258 : Piston pumps
• 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 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/508 : Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• CPC Class Codes: A61M 60/849 : Disposable parts
• CPC Class Codes: A61M 60/851 : Valves

Abstract

A hemodialysis system includes an on-line dialysate generator; a dialysate pump actuator configured to pump dialysate generated by the generator to a dialyzer; a conductivity sensor located adjacent to a temperature sensor upstream of the dialyzer; a blood pump actuator; an air detector; and a disposable cassette configured to carry dialysate pumped by the dialysate pump actuator, the disposable cassette including a conductivity sensor portion and a temperature sensor portion located to operate with the conductivity sensor and the temperature sensor, respectively, the disposable cassette further configured to carry blood pumped by the blood pump actuator and to provide an air detection portion located to operate with the air detector.

Claims

1. A hemodialysis system comprising:

an on-line dialysate generator;

a dialysate pump actuator configured to pump dialysate generated by the generator to a dialyzer;

a conductivity sensor located adjacent to a temperature sensor upstream of the dialyzer;

a blood pump actuator;

an air detector; and

a disposable cassette configured to carry dialysate pumped by the dialysate pump actuator, the disposable cassette including a combined conductivity and temperature sensor portion separate from and located so as to operate with the conductivity sensor and the temperature sensor, respectively, the combined conductivity and temperature sensor portion including a fluid chamber, the disposable cassette further configured to carry blood pumped by the blood pump actuator and to provide an air detection portion located to operate with the air detector.

2. The hemodialysis system of claim 1, wherein the temperature and conductivity sensors are used to help ensure that the dialysate has been mixed properly.

3. The hemodialysis system of claim 1, wherein the temperature sensor is housed or integrated with the conductivity sensor.

4. The hemodialysis system of claim 1, which includes an arterial pressure sensor, and wherein the disposable cassette includes an arterial blood flowpath having an arterial pressure sensor portion located to operate with the arterial pressure sensor.

5. The hemodialysis system of claim 1, wherein the disposable cassette includes a venous blood flowpath, the air detection portion located in the venous blood flowpath.

6. The hemodialysis system of claim 5, which includes a venous pressure sensor, and wherein the venous blood flowpath includes a venous pressure sensor portion located to operate with the venous pressure sensor.

7. The hemodialysis system of claim 5, which includes a venous blood valve, and wherein the venous blood flowpath includes a valve portion located to operate with the venous blood valve.

8. The hemodialysis system of claim 1, wherein the disposable cassette includes an arterial blood flowpath and a venous blood flowpath, at least one of the flowpaths in fluid communication with an air separation device.

9. The hemodialysis system of claim 8, wherein a portion of the arterial blood flowpath is operable with the blood pump actuator.

10. The hemodialysis system of claim 1, which includes a blood leak detector, and wherein the disposable cassette includes a dialysate flowpath including the conductivity and temperature sensor portion, and which further includes a blood leak detector portion located to operate with the blood leak detector.

11. The hemodialysis system of claim 1, which includes a heater and a bypass return line operable with the heater to aid in temperature control.

12. The hemodialysis system of claim 11, wherein the heater is a dialysate heater located between the on-line dialysate generator and the dialyzer.

13. The hemodialysis system of claim 1, which includes a valve actuator located between the on-line dialysate generator and the dialysate pump actuator.