Dialysis system with cassette based balance chambers and volumetric pumps

• US 9,572,919 B2
• Filed: 04/10/2015
• Issued: 02/21/2017
• 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:
  US14/683,343
• Publication Number:
  US 20150209499A1
• Time in Patent Office: 683 Days
• Field of Search: 604 401- 616
• US Class Current: 1/1
• 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 dialysis system includes a fresh dialysis fluid pump, a used dialysis fluid pump, a fresh fluid flow path, a used fluid flow path, and a dialysis fluid cassette carrying a balance chamber, the balance chamber including a first rigid portion, a second rigid portion, and a flexible sheet located between the first and second rigid portions, the flexible sheet dividing the balance chamber into (i) a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid pump via the fresh fluid flow path, wherein fresh dialysis fluid contacts the first rigid portion and a first side of the flexible sheet, and (ii) a used dialysis fluid compartment connected fluidly to the used dialysis fluid pump via the used fluid flow path, wherein used dialysis fluid contacts the second rigid portion and a second side of the flexible sheet.

Claims

1. A dialysis system comprising:

a fresh dialysis fluid pump;

a used dialysis fluid pump; and

a dialysis fluid cassette including at least one wall that forms a rigid fresh fluid flow path in fluid communication with the fresh dialysis fluid pump and a rigid used fluid flow path in fluid communication with the used dialysis fluid pump, the dialysis fluid cassette carrying a balance chamber, the balance chamber including a first rigid portion, a second rigid portion, and a flexible sheet located between the first and second rigid portions, the flexible sheet dividing the balance chamber into (i) a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid pump via the rigid fresh fluid flow path, wherein fresh dialysis fluid contacts the first rigid portion and a first side of the flexible sheet, and (ii) a used dialysis fluid compartment connected fluidly to the used dialysis fluid pump via the rigid used fluid flow path, wherein used dialysis fluid contacts the second rigid portion and a second side of the flexible sheet.

2. The dialysis system of claim 1, wherein the fresh dialysis fluid pump is a fresh dialysis fluid membrane pump, and the used dialysis fluid pump is a used dialysis fluid membrane pump.

3. The dialysis system of claim 2, wherein at least one of the fresh and used dialysis fluid membrane pumps is a pair of cooperating membrane pumps.

4. The dialysis system of claim 1, wherein the dialysis fluid cassette carries the balance chamber and the fresh and used dialysis fluid pumps.

5. The dialysis system of claim 1, wherein the rigid fresh fluid flow path and the rigid used fluid flow path are connected directly to the fresh dialysis fluid pump and the used dialysis fluid pump, respectively.

6. The dialysis system of claim 1, wherein the fresh dialysis fluid compartment of the balance chamber is fluidly connectable to a dialyzer.

7. The dialysis system of claim 1, wherein the dialysis fluid cassette provides a first valve located between the fresh dialysis fluid pump and the fresh dialysis fluid compartment of the balance chamber and a second valve located between the used dialysis fluid pump and the used dialysis fluid compartment of the balance chamber.

8. The dialysis system of claim 1, wherein the first and second rigid portions are each semi-spherical.

9. A dialysis system comprising:

a fresh dialysis fluid pump;

a used dialysis fluid pump; and

a dialysis fluid cassette including at least one wall that forms a first rigid fresh fluid flow path, a first rigid used fluid flow path, a second rigid fresh fluid flow path, and a second rigid used fluid flow a path, the dialysis fluid cassette carrying

a first balance chamber including a first rigid portion, 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 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 used dialysis fluid compartment connected fluidly to the used dialysis fluid pump via the first used fluid flow path, wherein used dialysis fluid contacts the second rigid portion and a second side of the flexible sheet, and

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 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 used dialysis fluid compartment connected fluidly to the used dialysis fluid pump via the second used fluid flow path, wherein used dialysis fluid contacts the second rigid portion and a second side of the flexible sheet.

10. The dialysis system of claim 9, wherein the fresh dialysis fluid pump is a fresh dialysis fluid membrane pump, and the used dialysis fluid pump is a used dialysis fluid membrane pump.

11. The dialysis system of claim 10, wherein at least one of the fresh and used dialysis fluid membrane pumps is a pair of cooperating membrane pumps.

12. The dialysis system of claim 9, wherein the dialysis fluid cassette carries the first and second balance chambers and the fresh and used dialysis fluid pumps.

13. The dialysis system of claim 9, wherein the first fresh fluid flow path is connected directly to the fresh dialysis fluid compartment of the first balance chamber, the second fresh fluid flow path is connected directly to the fresh dialysis fluid compartment of the second balance chamber, the first used fluid flow path is connected directly to the used dialysis fluid compartment of the first balance chamber, and the second used fluid flow is connected directly to the used dialysis fluid compartment of the second balance chamber.

14. The dialysis system of claim 9, wherein the dialysis fluid cassette provides a first valve located between the fresh dialysis fluid pump and each of the fresh dialysis fluid compartments of the first and second balance chambers and a second valve located between the used dialysis fluid pump and each of the used dialysis fluid compartments of the first and second balance chambers.

15. The dialysis system of claim 9, wherein the first and second rigid portions of the first and second balance chambers are each semi-spherical.

16. A dialysis system comprising:

a dialysis fluid cassette including at least one wall that forms a rigid fresh dialysis fluid flow path and a rigid used dialysis fluid flow path, the dialysis fluid cassette carrying a first rigid portion and a second rigid portion defining a chamber with a flexible sheet located between the first rigid portion and the second rigid portion to form a fresh dialysis fluid compartment and a used dialysis fluid compartment;

a fresh dialysis fluid membrane pump including a fluid receiving portion in fluid communication with the dialysis fluid cassette; and

a used dialysis fluid membrane pump including a fluid receiving portion in fluid communication with the dialysis fluid cassette,

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

17. The dialysis system of claim 16, wherein the dialysis fluid cassette includes fresh and used valves located respectively between (i) the fresh dialysis fluid membrane pump and the fresh dialysis fluid compartment and (ii) the used dialysis fluid membrane pump and the used dialysis fluid compartment.

18. The dialysis system of claim 16, wherein the chamber is spherical.

19. The dialysis system of claim 16, wherein the dialysis fluid cassette carries the chamber and the fresh and used dialysis fluid membrane pumps.

20. The dialysis system of claim 16, wherein the rigid fresh dialysis fluid flow path and the rigid used dialysis fluid flow path are connected directly to at least one of the fresh dialysis fluid membrane pump or the fresh dialysis fluid compartment, and at least one of the used dialysis fluid membrane pump or the used dialysis fluid compartment, respectively.