Dialysis system with a varying rate ultrafiltration profile

• US 9,550,020 B2
• Filed: 05/13/2015
• Issued: 01/24/2017
• 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:
  US14/710,898
• Publication Number:
  US 20150238680A1
• Time in Patent Office: 622 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 dialysis system includes a dialysis fluid cassette-based membrane blood pump; a dialyzer in fluid communication with the blood pump; first and second dialysis fluid cassette-based balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment; a dialysis fluid cassette-based fresh dialysis fluid membrane pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers; a dialysis fluid cassette-based spent dialysis fluid membrane pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers; and arterial and venous lines in fluid communication with the dialyzer for patient connection, the arterial and venous lines each including a contact used for electrically detecting a patient access disconnection.

Claims

1. A dialysis system comprising:

a membrane blood pump provided by a first cassette;

a dialyzer in fluid communication with the membrane blood pump;

first and second dialysis fluid balance chambers each provided with the first cassette or with a second cassette, the first and second dialysis fluid balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment;

a fresh dialysis fluid membrane pump provided with the first cassette or with the second cassette, the fresh dialysis fluid membrane pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers; and

a spent dialysis fluid membrane pump provided with the first cassette or with the second cassette, the spent dialysis fluid membrane pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers,

wherein the system is configured to operate according to a varying rate ultrafiltration profile, and

wherein the first and second balance chambers operate with the fresh dialysis fluid membrane pump and the spent dialysis fluid membrane pump such that

(i) during an exchange cycle, fresh dialysis fluid is sent to the dialyzer, and

(ii) during an ultrafiltration cycle, no fresh dialysis fluid is sent to the dialyzer, and the spent dialysis fluid is sent to a drain, and

(iii) a frequency of ultrafiltration cycles with respect to exchange cycles is variable according to the varying rate ultrafiltration profile.

2. The dialysis system of claim 1, wherein the system is configured to adjust operation of the first and second balance chambers according to the varying rate ultrafiltration profile.

3. The dialysis system of claim 1, which includes a processor programmed to run the varying rate ultrafiltration profile.

4. The dialysis system of claim 1, which is configured to enable the varying rate ultrafiltration profile to be user selected.

5. The dialysis system of claim 1, wherein the varying rate ultrafiltration profile varies the frequency of the ultrafiltration cycle by increasing or decreasing a number of the exchange cycles operated between ultrafiltration cycles.

6. The dialysis system of claim 1, wherein the varying rate ultrafiltration profile varies how often an ultrafiltration volume is removed.

7. The dialysis system of claim 1, which is configured to use the varying rate ultrafiltration profile with an entered treatment time to calculate an ultrafiltration frequency profile.

8. The dialysis system of claim 1, which is configured to use the varying rate ultrafiltration profile with an entered cumulative ultrafiltration volume to be removed to calculate an ultrafiltration frequency profile.

9. The dialysis system of claim 1, wherein the varying rate ultrafiltration profile enables more ultrafiltration to take place during a first part of a therapy relative to a second part of the therapy.

10. The dialysis system of claim 1, which includes a processor programmed to (i) enable a user to select (a) the varying rate ultrafiltration profile, (b) a total ultrafiltration volume to be removed, and (c) a treatment time, and (ii) calculate an ultrafiltration frequency profile, which removes the user selected total ultrafiltration volume over the user selected treatment time according to the user selected varying rate ultrafiltration profile.

11. The dialysis system of claim 10, which is configured to allow the user to select (a), (b) and (c) via a patient data card.

12. The dialysis system of claim 1, which includes arterial and venous lines in fluid communication with the dialyzer for patient connection, the arterial and venous lines each including a contact used for electrically detecting a patient access disconnection.

13. The dialysis system of claim 12, which is configured to use the arterial and venous contacts to sense a change in electrical impedance to detect the patient access disconnection.

14. The dialysis system of claim 12, which is configured to close at least one valve upon detecting the patient access disconnection.

15. A dialysis system comprising:

a membrane blood pump;

a dialyzer in fluid communication with the membrane blood pump;

first and second dialysis fluid balance chambers, the first and second dialysis fluid balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment;

a fresh dialysis fluid membrane pump, the fresh dialysis fluid membrane pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers; and

a spent dialysis fluid membrane pump, the spent dialysis fluid membrane pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers;

wherein the system is configured to operate according to a varying rate ultrafiltration profile in which a frequency of ultrafiltration cycles with respect to exchange cycles is varied, and

wherein the first and second balance chambers operate with the fresh dialysis fluid membrane pump and the spent dialysis fluid membrane pump such that

(i) during the exchange cycle, fresh dialysis fluid is sent to the dialyzer, and

(ii) during the ultrafiltration cycle, no fresh dialysis fluid is sent to the dialyzer and spent dialysis fluid in at least one of the first or second balance chambers is sent to a drain.

16. The dialysis system of claim 15, which is configured to adjust operation of the first and second balance chambers according to the varying rate ultrafiltration profile.

17. The dialysis system of claim 15, which includes a processor programmed to run the varying rate ultrafiltration profile.

18. The dialysis system of claim 15, wherein the varying rate ultrafiltration profile varies how often an ultrafiltration volume is removed.

19. The dialysis system of claim 15, which is configured to use the varying rate ultrafiltration profile with an entered treatment time to determine how to vary the ultrafiltration cycles with respect to the exchange cycles.

20. The dialysis system of claim 15, which is configured to use the varying rate ultrafiltration profile with an entered cumulative ultrafiltration volume to determine how to vary the ultrafiltration cycles with respect to the exchange cycles.