Dialysis system with balance chamber prime and rinseback

• US 9,480,784 B2
• Filed: 09/03/2015
• Issued: 11/01/2016
• 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: El Sayyid, Waleed M, Kelly, Thomas, Childers, Robert W., Busby, Don, Roger, Rodolfo, Din, Shahid
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/844,767
• Publication Number:
  US 20160030657A1
• Time in Patent Office: 425 Days
• Field of Search: 604 401- 616
• US Class Current: 1/1
• CPC Class Codes: A61M 1/1037 Pumps having flexible elements, e.g. with membranes, diaphragms, or bladder pumps Moving membranes in blood filters used for pumping A61M1/267
• 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 extracorporeal circuit, a dialysis fluid circuit including first and second balance chambers, a fresh dialysis fluid pump in fluid communication with first and second fresh compartments of the first and second balance chambers, respectively. The first and second fresh compartments are in fluid communication with a fresh dialysate fluid inlet of the dialyzer, and a used dialysis fluid pump is in fluid communication with first and second spent compartments of the first and second balance chambers, respectively. The system is configured to run a blood rinseback sequence in which (i) at least one of the fresh used dialysis fluid pumps is operated to pump dialysis fluid through the dialyzer and into the extracorporeal circuit and (ii) the blood pump is operated to push blood back to a patient connected to the extracorporeal circuit.

Claims

1. A dialysis system comprising:

an extracorporeal circuit including a blood pump;

a dialyzer in communication with the extracorporeal circuit, the dialyzer including a fresh dialysis fluid inlet and a used dialysis fluid outlet;

a dialysis fluid circuit including

a first balance chamber including a fresh compartment and a used compartment, the fresh compartment of the first balance chamber in fluid communication with the fresh dialysis fluid inlet of the dialyzer,

a second balance chamber including a fresh compartment and a used compartment, the fresh compartment of the second balance chamber in fluid communication with the fresh dialysis fluid inlet of the dialyzer,

a fresh dialysis fluid pump in fluid communication with the fresh compartment of the first balance chamber and the fresh compartment of the second balance chamber,

a used dialysis fluid pump in fluid communication with the used compartment of the first balance chamber and the used compartment of the second balance chamber, the used dialysis fluid pump also in fluid communication with the used dialysis fluid outlet of the dialyzer; and

wherein the system is configured to run a blood rinseback sequence in which (i) at least one of the fresh dialysis fluid pump or the used dialysis fluid pump is operated to pump dialysis fluid through the dialyzer and into the extracorporeal circuit and (ii) the blood pump is operated to push blood back to a patient connected to the extracorporeal circuit.

2. The dialysis system of claim 1, wherein the blood is operated to push blood back to the patient through an arterial line of the extracorporeal circuit.

3. The dialysis system of claim 1, wherein operating the blood pump includes reversing the blood pump at least one time.

4. The dialysis system of claim 1, which is configured to operate the blood pump at a speed that is lower than a speed during a dialysis treatment or a priming sequence so as to minimize the mixing of blood and dialysis fluid during the blood rinseback sequence.

5. The dialysis system of claim 1, wherein the blood pump includes a fluid contacting portion provided with a same disposable item as the dialyzer.

6. The dialysis system of claim 1, which includes at least one manual clamp for occluding a line of the extracorporeal circuit.

7. The dialysis system of claim 1, wherein the extracorporeal circuit includes an air trap, and wherein operating at least one of the fresh dialysis fluid pump and the used dialysis fluid pump includes pumping until a predetermined volume of dialysis fluid fills the air trap.

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

9. The dialysis system of claim 1, which includes a dialysis fluid cassette, wherein each of the fresh dialysis fluid pump, the used dialysis fluid pump, and the blood pump includes a fluid carrying portion located in the dialysis fluid cassette.

10. The dialysis system of claim 1, which includes a saline source, wherein operating the blood pump includes pulling saline from the saline source to push the blood back to the patient.

11. The dialysis system of claim 10, wherein the saline source pushes the blood back through the venous line of the extracorporeal circuit.

12. The dialysis system of claim 1, wherein the blood rinseback sequence includes operating at least one extracorporeal circuit valve with the operation of the blood pump.

13. The dialysis system of claim 12, wherein a fluid carrying portion of the blood pump and the at least one extracorporeal circuit valve are located in a single fluid disposable.

14. The dialysis system of claim 1, wherein the operating of the at least one fresh dialysis fluid pump or the used dialysis fluid pump includes pumping fresh dialysis fluid to send used dialysis fluid from the used compartment of the first balance chamber to the used compartment of the second balance chamber to drive fresh dialysis fluid to the dialyzer through the fresh dialysis fluid inlet.

15. A method of performing a blood rinseback sequence in a dialysis system including (i) an extracorporeal circuit having a blood pump, (ii) a dialyzer in communication with the extracorporeal circuit, and (iii) a dialysis fluid circuit in communication with the dialyzer and including a fresh dialysis fluid membrane pump and a used dialysis fluid membrane pump, the method comprising:

operating at least one of the fresh dialysis fluid membrane pump and the used dialysis fluid membrane pump so as to pump dialysis fluid through the dialyzer and into an extracorporeal circuit; and

operating the blood pump so as to push blood back to a patient connected to the extracorporeal circuit.

16. The method of claim 15, wherein operating the at least one fresh dialysis fluid membrane pump and the used dialysis fluid membrane pump includes pumping until a predetermined volume of dialysis fluid fills an air trap in the extracorporeal circuit.

17. The method of claim 15, which includes operating the blood pump by running the blood pump in forward and reverse directions.

18. The method of claim 15, which includes operating the blood pump at a speed that is slower than a speed during a priming sequence or a dialysis treatment so as minimize the mixing of blood and dialysis fluid.

19. The method of claim 15, which includes preventing air in the extracorporeal circuit from being pushed into the patient.

20. The method of claim 19, wherein preventing air in the extracorporeal circuit from being pushed into the patient includes clamping a blood line of the extracorporeal circuit if air is detected in the extracorporeal circuit.