Systems and methods for priming sorbent-based hemodialysis using dialysis fluid

• US 9,364,602 B2
• Filed: 01/24/2013
• Issued: 06/14/2016
• 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: Kelly, Thomas, Childers, Robert W., Busby, Don, Roger, Rodolfo, El Sayyid, Waleed Mutasem, Din, Shahid
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/749,309
• Publication Number:
  US 20130153495A1
• Time in Patent Office: 1,237 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 method for priming a hemodialysis treatment includes: providing a sorbent cartridge for cleaning spent dialysate fluid returning from a dialyzer; preparing a batch of dialysate in a quantity commensurate with being recycled through the sorbent cartridge multiple times; priming a dialysate circuit in fluid communication with the dialyzer using the batch of dialysate; and priming a blood circuit in fluid communication with the dialyzer using the batch of dialysate.

Claims

1. A method for priming a hemodialysis treatment comprising:

providing a sorbent cartridge for cleaning spent dialysate fluid returning from a dialyzer;

preparing a batch of dialysate in a quantity commensurate with being recycled through the sorbent cartridge multiple times;

priming a dialysate circuit in fluid communication with the dialyzer using the batch of dialysate; and

priming a blood circuit in fluid communication with the dialyzer using the batch of dialysate and reversing a blood pump at least one time to pump dialysate from the batch of dialysate.

2. The method of claim 1, wherein priming the blood circuit includes reversing the blood pump after a drip chamber is filled with fluid.

3. The method of claim 1, wherein preparing the batch of dialysate includes mixing water and concentrate.

4. The method of claim 1, wherein preparing the batch of dialysate includes using five liters of water to mix the dialysate.

5. The method of claim 1, wherein priming the blood circuit includes venting air through a vent.

6. The method of claim 1, wherein priming the blood circuit includes connecting the ends of arterial and venous lines of the blood circuit together.

7. The method of claim 1, which includes closing and opening at least one valve or line clamp in the blood circuit to prime the blood circuit.

8. The method of claim 1, which includes purifying the dialysate for priming the blood circuit.

9. The method of claim 1, wherein priming the blood circuit includes directing the dialysate at one time in a first direction towards an air trap located in the blood circuit and at another time in a second direction towards the dialyzer.

10. The method of claim 1, wherein priming the blood circuit includes directing the dialysate at one time in a treatment operation direction and at another time in a reverse of the treatment operation direction.

11. The method of claim 1, wherein priming the blood circuit includes back-filtering dialysate through the dialyzer.

12. A method for priming a hemodialysis treatment comprising:

providing a sorbent cartridge for cleaning spent dialysate fluid returning from a dialyzer;

preparing a batch of dialysate in a quantity commensurate with being recycled through the sorbent cartridge multiple times;

priming a dialysate circuit in fluid communication with the dialyzer using the batch dialysate; and

priming a blood circuit in fluid communication with the dialyzer using the batch of dialysate while operating a valve that is in a fluid line connected to the blood circuit.

13. The method of claim 12, wherein priming the blood circuit additionally includes using a biologically safe fluid other than dialysate to prime the blood circuit, the valve enabling the biologically safe fluid to enter the blood circuit.

14. The method of claim 12, wherein priming the blood circuit includes opening and closing the valve to flow dialysate in different directions within the blood circuit.

15. The method of claim 12, which includes using the valve to flow dialysate directly to the blood circuit, bypassing the dialyzer.

16. The method of claim 12, which includes using the valve to flow dialysate into the blood circuit between the dialyzer and an arterial line access connector.

17. The method of claim 12, wherein priming the blood circuit includes back-filtering dialysate through the dialyzer.

18. A dialysis machine configured and arranged to perform the method of claim 12.

19. A dialysis system comprising:

a batch container;

a sorbent cartridge;

first and second dialysate pumps;

a blood pump;

a dialyzer;

a dialysate circuit (i) in fluid communication with the batch container, the sorbent cartridge, and the dialyzer and (ii) in operable communication with the first and second dialysate pumps;

a blood circuit (i) in fluid communication with the dialyzer and (ii) in operable communication with the blood pump; and

at least one processor configured to operate a priming sequence in which dialysate prepared in the batch container is flowed to prime both the dialysate and blood circuits, and wherein the blood circuit is primed by reversing the blood pump at least one time.

20. The dialysis system of claim 19, which includes a valve, and wherein the at least one processor is configured and arranged to further operate the valve to enable dialysate to flow to the blood circuit, bypassing the dialyzer.

21. The dialysis system of claim 19, which includes a valve used by the processor to operate the priming sequence, the valve controlling a fluid line that connects to the blood circuit upstream of the dialyzer.

22. The dialysis system of claim 19, which includes a valve used by the processor to operate the priming sequence, the valve controlling a fluid line that connects to the blood circuit between the dialyzer and an arterial line access connector.

23. A dialysis system comprising:

a batch container;

a sorbent cartridge;

first and second dialysate pumps;

a blood pump;

a dialyzer;

a dialysate circuit (i) in fluid communication with the batch container, the sorbent cartridge, and the dialyzer and (ii) in operable communication with the first and second dialysate pumps;

a blood circuit (i) in fluid communication with the dialyzer, and (ii) in operable communication with the blood pump;

a fluid line connected to an arterial line of the blood circuit upstream of the dialyzer;

a valve in the fluid line; and

at least one processor configured to operate a sequence in which the valve is opened to enable dialysate to enter the blood circuit upstream of the dialyzer to prime the blood circuit.

24. A method for priming a hemodialysis treatment comprising:

providing a sorbent cartridge for cleaning spent dialysate fluid returning from a dialyzer;

preparing a batch of dialysate in a quantity commensurate with being recycled through the sorbent cartridge multiple times;

priming a dialysate circuit in fluid communication with the dialyzer using the batch of dialysate; and

priming a blood circuit in fluid communication with the dialyzer using the batch of dialysate and by connecting the ends of arterial and venous lines of the blood circuit together.