Dialysis system with cassette based balance chambers and volumetric pumps

• US 9,005,152 B2
• Filed: 09/17/2010
• Issued: 04/14/2015
• 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:
  US12/885,088
• Publication Number:
  US 20110005986A1
• Time in Patent Office: 1,670 Days
• Field of Search: 604 401- 616, 604/406, 604/19, 604 28- 30, 210 85- 88, 210/104, 210/321.6, 210645-647, 210/739, 210/767, 210/744, 210/321.71
• US Class Current: 604/6.11
• 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 a fresh dialysis fluid membrane pump; a spent dialysis fluid membrane pump; a first balance chamber having a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump and a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump; a second balance chamber having a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump and a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump; and a dialysis fluid cassette, wherein at least one of the fresh dialysis fluid membrane pump, the spent dialysis fluid membrane pump, the first balance chamber and the second balance chamber includes a fluid receiving portion provided in the dialysis fluid cassette.

Claims

1. A dialysis system comprising:

a fresh dialysis fluid membrane pump;

a spent dialysis fluid membrane pump;

a first fresh fluid flow path;

a first spent fluid flow path;

a second fresh fluid flow path;

a second spent fluid flow path;

a first balance chamber including a first rigid portion and a second rigid portion, and a flexible sheet located between the first and second rigid portions, the flexible sheet dividing the first balance chamber into (i) a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump via the first fresh fluid flow path, wherein fresh dialysis fluid contacts the first rigid portion and a first side of the flexible sheet, and (ii) a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump via the first spent fluid flow path, wherein spent dialysis fluid contacts the second rigid portion and a second side of the flexible sheet;

a second balance chamber including a first rigid portion and a second rigid portion, and a flexible sheet located between the first and second rigid portions, the flexible sheet dividing the second balance chamber into (i) a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump via the second fresh fluid flow path, wherein fresh dialysis fluid contacts the first rigid portion and a first side of the flexible sheet, and (ii) a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump via the second spent fluid flow path, wherein spent dialysis fluid contacts the second rigid portion and a second side of the flexible sheet; and

a dialysis fluid cassette carrying and in fluid communication with the first and second balance chambers, the dialysis fluid cassette including a fluid receiving portion for the fresh dialysis fluid membrane pump and a fluid receiving portion for the spent dialysis fluid membrane pump, wherein the first and second fresh fluid flow paths and the first and second spent fluid flow paths are provided by the dialysis fluid cassette.

2. The dialysis system of claim 1, wherein each of the pumps and balance chambers includes a fluid receiving portion provided by the dialysis fluid cassette.

3. The dialysis system of claim 1, wherein at least one of the fresh and spent dialysis fluid membrane pumps is a pair of cooperating membrane pumps.

4. The dialysis system of claim 1, which includes an inline fluid heater located between the fresh dialysis fluid membrane pump and the first and second balance chambers.

5. The dialysis system of claim 1, wherein the fresh dialysis fluid compartment of each of the first and second balance chambers is fluidly connectable to a dialyzer.

6. The dialysis system of claim 5, which is configured to place the spent dialysis fluid membrane pump in fluid communication with the dialyzer.

7. The dialysis system of claim 1, which includes a separate valve located between the fresh dialysis fluid membrane pump and each of the fresh dialysis fluid compartments of the first and second balance chambers and a separate valve located between the spent dialysis fluid membrane pump and each of the spent dialysis fluid compartments of the first and second balance chambers.

8. The dialysis system of claim 7, wherein each of the valves includes a fluid receiving portion provided in the dialysis fluid cassette.

9. The dialysis system of claim 1, which is configured to place the fresh dialysis fluid membrane pump in fluid communication with an online source of dialysis fluid.

10. The dialysis system of claim 1, which is configured to place the fresh dialysis fluid membrane pump in fluid communication with at least one container of dialysis fluid.

11. The dialysis system of claim 1, wherein the first and second rigid portions of at least one of the first and second balance chambers are defined by an at least substantially spherical chamber.

12. The dialysis system of claim 1, wherein at least one of the first and second balance chambers includes a single port connection to each of its fresh and spent dialysis fluid compartments.

13. The dialysis system of claim 1, which further includes a volumetric cassette-based diaphragm blood pump.

14. A dialysis system comprising:

a fresh dialysis fluid flow path;

a spent dialysis fluid flow path;

a dialysis fluid cassette providing the fresh and spent dialysis fluid flow paths and carrying and in fluid communication with a first rigid portion and a second rigid portion, the first and second rigid portions defining a chamber, a flexible sheet located between the rigid portions so as to form a fresh dialysis fluid compartment and a spent dialysis fluid compartment;

a fresh dialysis fluid membrane pump including a fluid receiving portion provided by the dialysis fluid cassette; and

a spent dialysis fluid membrane pump including a fluid receiving portion provided by the dialysis fluid cassette,

wherein the fresh dialysis fluid membrane pump is in fluid communication with the fresh dialysis fluid compartment via the fresh dialysis fluid flow path and the spent dialysis fluid membrane pump is in fluid communication with the spent dialysis fluid compartment via the spent dialysis fluid flow path, the fresh dialysis fluid membrane pump causing fresh fluid to contact the first rigid portion and a first side of the flexible sheet forming the fresh dialysis fluid compartment, the spent dialysis fluid membrane pump causing spent fluid to contact the second rigid portion and a second side of the flexible sheet forming the spent dialysis fluid compartment.

15. The dialysis system of claim 14, wherein the fluid receiving portions of the fresh and spent dialysis fluid membrane pumps are at least substantially spherical.

16. The dialysis system of claim 14, which includes fresh and spent valves located respectively between (i) the fresh dialysis fluid membrane pump and the fresh dialysis fluid compartment and (ii) the spent dialysis fluid membrane pump and the spent dialysis fluid compartment.

17. The dialysis system of claim 16, wherein the dialysis fluid cassette further includes fluid carrying portions of the fresh and spent valves.

18. The dialysis system of claim 16, wherein the first rigid portion defines a first single flowpath to the fresh dialysis fluid compartment and the second rigid portion defines a second single flowpath to the spent dialysis fluid compartment.

19. A dialysis system comprising:

a dialysis machine; and

a dialysis fluid cassette configured and arranged to operate with the dialysis machine, the dialysis fluid cassette including fluid carrying portions for,

a fresh membrane pump pair including first and second membrane pumps, the first membrane pump provided in parallel with the second membrane pump,

a spent membrane pump pair including third and fourth membrane pumps, the third membrane pump provided in parallel with the fourth membrane pump,

a first balance chamber including a fresh dialysis fluid compartment and a spent dialysis fluid compartment, the first and second membrane pumps of the fresh membrane pump pair in fluid communication with the fresh dialysis fluid compartment of the first balance chamber, the third and fourth membrane pumps of the spent membrane pump pair in fluid communication with the spent dialysate fluid compartment of the first balance chamber, and

a second balance chamber including a fresh dialysis fluid compartment and a spent dialysis fluid compartment, the first and second membrane pumps of the fresh membrane pump pair in fluid communication with the fresh dialysis fluid compartment of the second balance chamber, the third and fourth membrane pumps of the spent membrane pump pair in fluid communication with the spent dialysate fluid compartment of the second balance chamber.

20. The dialysis system of claim 19, wherein the first and second membrane pumps of the fresh membrane pump pair output to a common fresh dialysis fluid line.