Dialysis system including automatic priming

• US 9,889,243 B2
• Filed: 10/12/2016
• Issued: 02/13/2018
• 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:
  US15/291,806
• Publication Number:
  US 20170028120A1
• Time in Patent Office: 489 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 hemodialysis system comprising: a source of priming fluid; an extracorporeal circuit including an arterial line, a venous line, and a drip chamber; a level sensor operable with the drip chamber; a reversible blood pump operable with the extracorporeal circuit; a connection between the arterial and the venous line; and a priming sequence in which priming fluid from the source is pumped in a reverse pump direction through the extracorporeal circuit and reversibly in a normal pump direction through the extracorporeal circuit, wherein an output from the level sensor is used to determine when to stop pumping in at least one of the directions.

Claims

1. A hemodialysis system comprising:

a source of priming fluid;

an extracorporeal circuit including an arterial line, a venous line, and a drip chamber;

a level sensor operable with the drip chamber;

a reversible blood pump operable with the extracorporeal circuit;

a connection between the arterial line and the venous line; and

a priming sequence in which priming fluid from the source is pumped in a reverse pump direction through the extracorporeal circuit and oppositely in a normal pump direction through the extracorporeal circuit, wherein an output from the level sensor is used to determine when to stop pumping in at least one of the directions.

2. The hemodialysis system of claim 1, wherein the connection is made at non-dialyzer ends of the arterial and venous lines.

3. The hemodialysis system of claim 1, wherein the priming fluid is saline.

4. The hemodialysis system of claim 1, wherein the priming fluid is dialysate.

5. The hemodialysis system of claim 4, wherein the extracorporeal circuit is in fluid communication with a dialyzer and the dialysate is pumped into the extracorporeal circuit through the dialyzer.

6. The hemodialysis system of claim 1, wherein priming fluid in the priming sequence is pumped in the reverse pump direction multiple times through the extracorporeal circuit and oppositely in the normal pump direction multiple times through the extracorporeal circuit, and wherein an output from the level sensor is used at least one time to determine when to switch directions.

7. The hemodialysis system of claim 6, wherein priming fluid is pumped in the reverse pump direction and oppositely in the normal pump direction until the extracorporeal circuit is fully primed.

8. The hemodialysis system of claim 1, wherein the drip chamber is vented, and wherein air during the priming sequence is vented through the drip chamber.

9. The hemodialysis system of claim 1, wherein the priming fluid is pumped initially through the extracorporeal circuit in the reverse pump direction.

10. The hemodialysis system of claim 1, wherein the priming source includes a saline source in fluid communication with the extracorporeal circuit via a saline line, the saline line operable with a valve to selectively allow saline to flow to the extracorporeal circuit.

11. The hemodialysis system of claim 10, wherein the saline line includes a first branch placed in fluid communication with the extracorporeal circuit on a first side of the blood pump and a second branch placed in fluid communication with the extracorporeal circuit on a second side of the blood pump, wherein the valve is a first valve operable with the first branch, and which includes a second valve operable with the second branch, the priming sequence opening and closing the first and second valves such that saline is pumped through the blood pump in both the reverse pump direction and oppositely in the normal pump direction.

14. The hemodialysis system of claim 1, wherein the fluid is pumped initially through the extracorporeal circuit in the reverse pump direction.

15. The hemodialysis system of claim 1, wherein the fluid is saline or dialysate.

12. A hemodialysis system comprising:

an extracorporeal circuit including an arterial line, a venous line, and a drip chamber;

a level sensor operable with the drip chamber;

a reversible blood pump operable with the extracorporeal circuit;

a connection between the arterial line and the venous line; and

a priming sequence in which fluid is pumped in a reverse pump direction multiple times through the extracorporeal circuit and in a normal pump direction multiple times through the extracorporeal circuit, wherein an output from the level sensor is used to determine when to stop pumping in at least one of the directions.

13. The hemodialysis system of claim 12, wherein fluid is pumped in the reverse pump direction and the normal pump direction multiple times through the extracorporeal circuit until the extracorporeal circuit is fully primed.

16. A hemodialysis priming method comprising:

pumping a priming fluid in a first direction through an extracorporeal circuit including an arterial line connected at its distal end to a distal end of a venous line, the extracorporeal circuit further including a drip chamber operable with a level sensor;

enabling air to be displaced through the drip chamber as priming fluid is pumped in the first direction through the extracorporeal circuit;

stopping the pumping of the priming fluid in the first direction;

upon stopping the pumping of the priming fluid in the first direction, pumping the priming fluid in a second direction through the extracorporeal circuit including the arterial line connected at its distal end to the distal end of the venous line;

enabling air to be displaced through the drip chamber as priming fluid is pumped in the second direction through the extracorporeal circuit; and

stopping the pumping of the priming fluid in the second direction when the priming fluid reaches a predetermined level in the drip chamber as indicated by the level sensor.

17. The method of claim 16, wherein enabling air to be displaced through the drip chamber includes enabling air to be displaced through a hydrophobic vent.

18. The method of claim 16, wherein the first direction is a reverse pump direction and the second direction is a normal pump direction.

19. The method of claim 16, wherein pumping priming fluid in the first and second directions includes using a blood pump to pump the priming fluid.

20. The method of claim 16, wherein upon stopping the pumping of the priming fluid in the second direction, further pumping the priming fluid a second time in the first direction through the extracorporeal circuit including the arterial line connected at its distal end to the distal end of the venous line.