Systems and methods for priming hemodialysis using dialysis fluid

• US 10,245,369 B2
• Filed: 05/24/2016
• Issued: 04/02/2019
• 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:
  US15/163,128
• Publication Number:
  US 20160263306A1
• Time in Patent Office: 1,043 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 method for priming a hemodialysis treatment includes: providing a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit; placing a dialyzer in fluid communication with the dialysate circuit via a to-dialyzer dialysate line and a from-dialyzer dialysate line; placing the dialyzer in fluid communication with the blood circuit via an arterial blood line and a venous blood line; placing a source of dialysis fluid in fluid communication with the dialyzer; priming the dialysate circuit with dialysis fluid from the source while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and priming the blood circuit with dialysis fluid from the source by actuating at least one valve provided by the disposable cassette.

Claims

1. A method for priming a hemodialysis treatment comprising:

providing a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit;

placing a dialyzer in fluid communication with the dialysate circuit via a to-dialyzer dialysate line and a from-dialyzer dialysate line;

placing the dialyzer in fluid communication with the blood circuit via an arterial blood line and a venous blood line;

placing a source of dialysis fluid in fluid communication with the dialyzer;

priming the dialysate circuit with dialysis fluid from the source while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and

priming the blood circuit with dialysis fluid from the source by actuating at least one valve provided by the disposable cassette.

2. The method of claim 1, wherein priming the blood circuit includes reversing a blood pump at least one time.

3. The method of claim 2, which includes reversing the blood pump after a drip chamber is filled with fluid.

4. The method of claim 1, wherein priming the blood circuit includes connecting patient ends of the arterial blood line and the venous blood line together.

5. The method of claim 1, which includes actuating at least one valve in the blood circuit to prime the blood circuit.

6. The method of claim 1, wherein priming the blood circuit includes directing the dialysis fluid at one time in a first direction away from the dialyzer and at another time in a second direction towards the dialyzer.

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

8. The method of claim 1, wherein priming the blood circuit includes pumping the dialysis fluid through the dialyzer.

9. A dialysis machine configured and arranged to perform the method of claim 1.

10. A method for priming a hemodialysis treatment comprising:

providing a sorbent cartridge for cleaning used dialysis fluid returning from a dialyzer;

preparing a batch of dialysis fluid 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 dialysis fluid, while both a to-dialyzer dialysate line and a from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and

priming a blood circuit in fluid communication with the dialyzer using the batch of dialysis fluid.

11. The method of claim 10, wherein preparing the batch of dialysis fluid includes mixing water and concentrate.

12. The method of claim 10, wherein priming the blood circuit includes pumping dialysis fluid from the batch of dialysis fluid through the dialyzer.

13. The method of claim 10, wherein priming the blood circuit includes connecting patient ends of an arterial blood line connected to the blood circuit and a venous blood line connected to the blood circuit together.

14. A dialysis machine configured and arranged to perform the method of claim 10.

15. A dialysis system comprising:

a dialyzer;

a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit, the dialysate circuit in fluid communication with the dialyzer via a to-dialyzer dialysate line and a from-dialyzer dialysate line, the blood circuit in fluid communication with the dialyzer via an arterial blood line and a venous blood line;

a source of dialysis fluid in fluid communication with the dialyzer;

at least one dialysis fluid pump configured to pump dialysis fluid from the source of dialysis fluid through the dialysate circuit;

at least one blood pump configured to pump blood from a patient through the blood circuit; and

at least one processor configured to operate a sequence in which (i) the dialysate circuit is primed with dialysis fluid from the source of dialysis fluid while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and

(ii) the blood circuit is primed with dialysis fluid from the source of dialysis fluid by actuating at least one valve provided by the disposable cassette.

16. The dialysis system of claim 15, wherein the source of dialysis fluid includes regenerated dialysis fluid from a sorbent cartridge.

17. The dialysis system of claim 15, wherein the at least one processor reverses the at least one blood pump at least one time to prime the blood circuit.

18. The dialysis system of claim 15, wherein the at least one valve is located in the portion of the blood circuit included in the disposable cassette.

19. The dialysis system of claim 15, wherein the at least one valve is in fluid communication with the arterial blood line.

20. The dialysis system of claim 15, wherein the at least one processor is configured to prime the blood circuit with patient ends of the arterial blood line and the venous blood line connected together.