Systems and methods for priming hemodialysis using multiple fluid sources

• US 10,426,883 B2
• Filed: 02/08/2019
• Issued: 10/01/2019
• Est. Priority Date: 11/05/2003
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: 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:
  US16/271,417
• Publication Number:
  US 20190167885A1
• Time in Patent Office: 235 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 configured to purge air from a blood circuit comprising: a dialyzer; a dialysis fluid circuit operable with the dialyzer via dialysis fluid inlet and outlet lines; the blood circuit operable with the dialyzer and including an arterial line, a venous line, a blood pump operable with the arterial line upstream of the dialyzer, and a physiologically acceptable fluid source in fluid communication with the arterial line upstream of the blood pump; and an air purging scheme wherein, with the dialysis fluid inlet and outlet lines connected to the dialyzer, air is purged using dialysis fluid or other physiologically acceptable fluid pumped by at least one of the fresh or used dialysis fluid pumps from the dialysis fluid circuit, through the dialyzer, into the blood circuit, in combination with dialysis fluid or other physiologically acceptable fluid from the source introduced directly into the blood circuit.

Claims

1. A hemodialysis system configured to purge air from a blood circuit, the hemodialysis system comprising:

a dialyzer;

a dialysis fluid circuit in fluid communication with the dialyzer via dialysis fluid inlet and outlet lines, the dialysis fluid circuit including

a fresh dialysis fluid pump,

a used dialysis fluid pump,

a first balancing unit including (i) a first fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (ii) a first used dialysis fluid chamber operable with the used dialysis fluid pump, and

a second balancing unit including (i) a second fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (ii) a second used dialysis fluid chamber operable with the used dialysis fluid pump;

the blood circuit in fluid communication with the dialyzer and including

an arterial line for removing blood from a patient and delivering the blood to the dialyzer,

a venous line for returning blood from the dialyzer to the patient,

a blood pump operable with the arterial line upstream of the dialyzer,

a physiologically acceptable fluid source in fluid communication with the arterial line upstream of the blood pump, and

a drip chamber located along the venous line; and

an air purging scheme wherein, with the dialysis fluid inlet and outlet lines connected to the dialyzer, air is purged from the blood circuit using dialysis fluid or other physiologically acceptable fluid pumped through the dialysis fluid circuit, in combination with dialysis fluid or other physiologically acceptable fluid from the source introduced directly to the blood circuit.

2. The hemodialysis system of claim 1, wherein (i) the first fresh dialysis fluid chamber is located between the fresh dialysis fluid pump and a dialysis fluid inlet line to the dialyzer, (ii) the used dialysis fluid pump is located between the first used dialysis fluid chamber and a dialysis fluid outlet line from the dialyzer, (iii) the second fresh dialysis fluid chamber is located between the fresh dialysis fluid pump and the dialysis fluid inlet line to the dialyzer and (iv) the used dialysis fluid pump is located between the second used dialysis fluid chamber and the dialysis fluid outlet line from the dialyzer.

3. The hemodialysis system of claim 1, wherein the physiologically acceptable fluid source is a saline fluid source.

4. The hemodialysis system of claim 1, which includes an occluding device located along a line leading from the physiologically acceptable fluid source to the blood circuit, the occluding device operated during the air purging scheme.

5. The hemodialysis system of claim 1, wherein the arterial line and the venous line are disconnected from the patient during the air purging scheme.

6. The hemodialysis system of claim 1, wherein the blood pump is operated while introducing dialysis fluid or other physiologically acceptable fluid from the source directly into the blood circuit.

7. The hemodialysis system of claim 1, wherein dialysis fluid or saline is pumped via one or more of the fresh and used dialysis fluid pumps through the dialysis fluid circuit, the dialyzer and into the blood circuit during the air purging scheme.

8. A hemodialysis system configured to purge air from a blood circuit, the hemodialysis system comprising:

a dialyzer;

a dialysis fluid circuit in fluid communication with the dialyzer via dialysis fluid inlet and outlet lines, the dialysis fluid circuit including

a fresh dialysis fluid pump,

a used dialysis fluid pump,

a first balancing unit including (i) a first fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (ii) a first used dialysis fluid chamber operable with the used dialysis fluid pump, and

a second balancing unit including (i) a second fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (ii) a second used dialysis fluid chamber operable with the used dialysis fluid pump;

the blood circuit in fluid communication with the dialyzer and including an arterial line for removing blood from a patient and delivering the blood to the dialyzer,

a venous line for returning blood from the dialyzer to the patient,

a blood pump operable with the arterial line upstream of the dialyzer,

a physiologically acceptable fluid source in fluid communication with the arterial line upstream of the blood pump, and

a drip chamber located along the venous line; and

an air purging scheme wherein, with the dialysis fluid inlet and outlet lines connected to the dialyzer, air is purged using dialysis fluid or other physiologically acceptable fluid pumped from the dialysis fluid circuit, through the dialyzer, into the blood circuit, in combination with dialysis fluid or other physiologically acceptable fluid from the source introduced directly into the blood circuit.

9. The hemodialysis system of claim 8, wherein (i) the first fresh dialysis fluid chamber is located between the fresh dialysis fluid pump and a dialysis fluid inlet line to the dialyzer, (ii) the used dialysis fluid pump is located between the first used dialysis fluid chamber and a dialysis fluid outlet line from the dialyzer, (iii) the second fresh dialysis fluid chamber is located between the fresh dialysis fluid pump and the dialysis fluid inlet line to the dialyzer and (iv) the used dialysis fluid pump is located between the second used dialysis fluid chamber and the dialysis fluid outlet line from the dialyzer.

10. The hemodialysis system of claim 8, wherein the physiologically acceptable fluid source is a saline fluid source.

11. The hemodialysis system of claim 8, which includes an occluding device located along a line leading from the physiologically acceptable fluid source to the blood circuit, the occluding device operated during the air purging scheme.

12. The hemodialysis system of claim 8, wherein the arterial line and the venous line are disconnected from the patient during the air purging scheme.

13. The hemodialysis system of claim 8, wherein the blood pump is operated while introducing dialysis fluid or other physiologically acceptable fluid from the source directly into the blood circuit.

14. The hemodialysis system of claim 8, wherein dialysis fluid or saline is pumped via one or more of the fresh and used dialysis fluid pumps through the dialysis fluid circuit, the dialyzer and into the blood circuit during the air purging scheme.

15. A hemodialysis system configured to purge air from a blood circuit, the hemodialysis system comprising:

a dialyzer;

a dialysis fluid circuit in fluid communication with the dialyzer via dialysis fluid inlet and outlet lines, the dialysis fluid circuit including

a fresh dialysis fluid pump, and

a used dialysis fluid pump;

the blood circuit in fluid communication with the dialyzer and including

an arterial line for removing blood from a patient and delivering the blood to the dialyzer,

a venous line for returning blood from the dialyzer to the patient,

a blood pump operable with the arterial line upstream of the dialyzer, and

a physiologically acceptable fluid source in fluid communication with the arterial line upstream of the blood pump; and

an air purging scheme wherein, with the dialysis fluid inlet and outlet lines connected to the dialyzer, air is purged using dialysis fluid or other physiologically acceptable fluid pumped by at least one of the fresh dialysis fluid pump or the used dialysis fluid pump from the dialysis fluid circuit, through the dialyzer, into the blood circuit, in combination with dialysis fluid or other physiologically acceptable fluid from the source introduced directly into the blood circuit.

16. The hemodialysis system of claim 15, wherein the dialysis fluid circuit comprises a first balancing unit including (i) a first fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (ii) a first used dialysis fluid chamber operable with the used dialysis fluid pump, and a second balancing unit including (iii) a second fresh dialysis fluid chamber operable with the fresh dialysis fluid pump and (iv) a second used dialysis fluid chamber operable with the used dialysis fluid pump.

17. The hemodialysis system of claim 15, wherein the blood pump is operated while introducing dialysis fluid or other physiologically acceptable fluid from the source directly into the blood circuit.

18. The hemodialysis system of claim 15, wherein the blood pump is operated while air is purged using dialysis fluid or other physiologically acceptable fluid pumped by at least one of the fresh dialysis fluid pump or the used dialysis fluid pump from the dialysis fluid circuit, through the dialyzer, into the blood circuit.

19. The hemodialysis system of claim 15, which includes an occluding device located along a line leading from the physiologically acceptable fluid source to the blood circuit, the occluding device operated during the air purging scheme.

20. The hemodialysis system of claim 15, wherein the arterial line and the venous line are disconnected from the patient during the air purging scheme.