Hemodialysis system including a disposable cassette

• US 10,183,109 B2
• Filed: 04/04/2016
• Issued: 01/22/2019
• 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:
  US15/090,084
• Publication Number:
  US 20160213830A1
• Time in Patent Office: 1,023 Days
• 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 dialysis system includes an on-line dialysate generator, a first dialysate pump in fluid communication with the on-line dialysate generator, and a second dialysate pump in fluid communication with the on-line dialysate generator. The dialysis system also includes a dialyzer in fluid communication with the first and second dialysate pumps. The dialysis system further includes a first valve located between the first dialysate pump and the dialyzer and a second valve located between the second dialysate pump and the dialyzer. The dialysis system is configured to alternate pumping of dialysate from the first and second dialysate pumps to the dialyzer using the first and second valves.

Claims

1. A hemodialysis system comprising:

an on-line dialysate generator;

a first dialysate pump in fluid communication with the on-line dialysate generator;

a second dialysate pump in fluid communication with the on-line dialysate generator;

a dialyzer positioned and arranged to receive dialysate pumped by the first and second dialysate pumps; and

a first valve located between the first dialysate pump and the dialyzer and a second valve located between the second dialysate pump and the dialyzer, the hemodialysis system configured to alternate pumping of dialysate from the first and second dialysate pumps towards the dialyzer using the first and second valves.

2. The hemodialysis system of claim 1, which includes a conductivity sensor configured to measure a composition of the dialysate from the on-line dialysate generator.

3. The hemodialysis system of claim 2, wherein the conductivity sensor is located between the dialysate pumps and the dialyzer.

4. The hemodialysis system of claim 1, wherein at least one of the first dialysate pump and the second dialysate pump includes a volumetric pumping device.

5. The hemodialysis system of claim 1, which includes third and fourth dialysate pumps that are alternating from-dialyzer pumps.

6. The hemodialysis system of claim 1, which includes a third pump configured and arranged to pull effluent from the dialyzer.

7. The hemodialysis system of claim 1, which includes:

a third valve located between the first dialysate pump and the on-line dialysate generator; and

a fourth valve located between the between the second dialysate pump and the on-line dialysate generator.

8. The hemodialysis system of claim 7, which is configured to:

deliver the dialysate to the first dialysate pump by closing the first valve and opening the third valve; and

deliver the dialysate to the second dialysate pump by closing the second valve and opening the fourth valve.

9. The hemodialysis system of claim 7, which is configured to alternate pumping of the first dialysate pump and the second dialysate pump by alternating the opening of the third and fourth valves in sequence with the alternating of the first and second valves.

10. The hemodialysis system of claim 1, which includes a controller configured to:

determine an amount of the dialysate pumped via the first and second dialysate pumps;

compare the determined amount of the dialysate to an expected amount; and

responsive to determining a difference between the determined amount and the expected amount, adjust a pumping rate of the first and second dialysate pumps.

11. The hemodialysis system of claim 1, which includes a balance chamber located between the first and second valves and the dialyzer.

12. A hemodialysis system comprising:

an on-line dialysate generator;

a first dialysate pump in fluid communication with the on-line dialysate generator;

a second dialysate pump in fluid communication with the on-line dialysate generator;

a dialyzer positioned and arranged to receive dialysate pumped by the first and second dialysate pumps;

a first valve located between the first dialysate pump and the dialyzer;

a second valve located between the second dialysate pump and the dialyzer;

a third valve located between the on-line dialysate generator and the first dialysate pump; and

a fourth valve located between the on-line dialysate generator and the second dialysate pump,

wherein the first and fourth valves are open and closed together and the second and third valves are opened and closed together to alternate the pumping of dialysate via the first and second dialysate pumps to the dialyzer.

13. The hemodialysis system of claim 12, which includes a bypass line having a first end in fluid communication with the first and second valves and the dialyzer and a second end in fluid communication with a drain.

14. The hemodialysis system of claim 12, which includes a balance chamber located between the first and second valves and the dialyzer.

15. The hemodialysis system of claim 14, wherein the balance chamber includes a fresh compartment in fluid communication with the first and second dialysate pumps.

16. The hemodialysis system of claim 14, wherein the balance chamber includes an effluent compartment for receiving effluent fluid from the dialyzer.

17. The hemodialysis system of claim 14, wherein the balance chamber is a first balance chamber, and which includes a second balance chamber located between the first and second valves and the dialyzer.

18. A hemodialysis system comprising:

an on-line dialysate generator;

a first dialysate pump in fluid communication with the on-line dialysate generator;

a second dialysate pump in fluid communication with the on-line dialysate generator;

first and second balance chambers in fluid communication with the first and second dialysate pumps;

a first valve located between the first dialysate pump and the balance chambers; and

a second valve located between the second dialysate pump and the balance chambers,

wherein pumping from the first and second dialysate pumps to the balance chambers is alternated using the first and second valves.

19. The hemodialysis system of claim 18, wherein the first and second dialysate pumps are volumetric pumps.

20. The hemodialysis system of claim 18, which includes third and fourth valves associated respectively with the first and second balance chambers, the third and fourth valves configured to enable dialysate from the first and second dialysate pumps to be delivered alternatively to the first and second balance chambers.