Hemodialysis system using sorbent and reservoir

• US 9,155,825 B2
• Filed: 08/19/2011
• Issued: 10/13/2015
• 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:
  US13/213,350
• Publication Number:
  US 20110297593A1
• Time in Patent Office: 1,516 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 hemodialysis system including (i) a dialyzer; (ii) a blood circuit including a blood pump in fluid communication with the dialyzer; (iii) a dialysate circuit including a dialysate circulation pump in fluid communication with the dialyzer, at least a portion of the dialysate circuit incorporated into a disposable dialysate cassette; (iv) a sorbent cartridge for cleaning used dialysate flowing in the dialysate circuit; (v) a reservoir holding an initial supply of dialysate; (vi) a reservoir pump in fluid communication with the dialysate circuit and the reservoir; (vii) a supply of infusate; and (viii) an infusate pump in fluid communication with the dialysate circuit and the supply of infusate.

Claims

1. A hemodialysis system comprising:

a dialyzer;

a blood circuit including a blood pump in fluid communication with the dialyzer;

a dialysate circuit including a dialysate circulation pump in fluid communication with the dialyzer, at least a portion of the dialysate circuit incorporated into a disposable dialysate cassette;

a sorbent cartridge for cleaning used dialysate flowing in the dialysate circuit;

a reservoir holding an initial supply of dialysate mixed from water and concentrate in the reservoir;

a reservoir pump in fluid communication with the dialysate circuit and the reservoir;

a supply of infusate; and

an infusate pump in fluid communication with the dialysate circuit and the supply of infusate.

2. The hemodialysis system of claim 1, wherein the reservoir is a rigid reservoir.

3. The hemodialysis system of claim 1, wherein at least the dialysate circulation pump and the reservoir pump include fluid carrying portions incorporated into the disposable dialysate cassette.

4. The hemodialysis system of claim 1, wherein the initial supply of dialysate is mixed using five liters of water.

5. The hemodialysis system of claim 1, wherein the reservoir includes an inlet and an outlet in fluid communication with the dialysate circuit.

6. The hemodialysis system of claim 1, wherein the supply of infusate includes at least one of:

calcium, magnesium or potassium.

7. The hemodialysis system of claim 1, which includes at least one filter to filter dialysate flowing from the reservoir and through the dialysate circuit.

8. The hemodialysis system of claim 1, which includes a supply of saline to prime the blood circuit.

9. The hemodialysis system of claim 1, which includes a heater to heat dialysate flowing through the dialysate circuit.

10. The hemodialysis system of claim 1, wherein dialysate leaving the sorbent cartridge enters the reservoir.

11. The hemodialysis system of claim 1, which includes a shunt line placed in the dialysate circuit for enabling the dialyzer to be bypassed for system startup.

12. The hemodialysis system of claim 1, which includes a conductivity sensor for determining if dialysate from the reservoir is within an acceptable physiological range.

13. The hemodialysis system of claim 1, wherein the dialysate circuit includes a bypass that allows the dialysate to be recirculated back to the reservoir instead of to the dialyzer.

14. A hemodialysis system comprising:

a disposable cassette;

a dialyzer;

a blood circuit including a blood pump in fluid communication with the dialyzer;

a dialysate circuit including a dialysate circulation pump in fluid communication with the dialyzer, at least a portion of the dialysate circuit provided by the disposable cassette;

a sorbent cartridge for cleaning used dialysate flowing in the dialysate circuit;

a dialysate reservoir receiving dialysate from the sorbent cartridge;

a reservoir pump positioned and arranged to communicate dialysate from the dialysate reservoir to the dialyzer;

a supply of infusate; and

an infusate pump in fluid communication with the supply of infusate for supplying infusate to the dialysate circuit, the infusate pump positioned and arranged to pump infusate from the supply of infusate directly to the reservoir.

15. The hemodialysis system of claim 14, wherein the blood pump and the dialysate circulation pump include blood and dialysate fluid carrying portions, respectively, provided by the disposable cassette.

16. The hemodialysis system of claim 14, wherein the dialysate reservoir receives an initial supply of dialysate.

17. The hemodialysis system of claim 14, wherein the dialysate reservoir receives pre-mixed dialysate.

18. The hemodialysis system of claim 17, wherein the pre-mixed dialysate is provided in a bag of dialysate.

19. A hemodialysis system comprising:

a disposable cassette;

a dialyzer in fluid communication with the disposable cassette;

a blood circuit including a blood pump in fluid communication with the dialyzer, the blood pump including a blood carrying portion provided by the disposable cassette;

a dialysate circuit including a dialysate circulation pump in fluid communication with the dialyzer, the dialysate circulation pump including a dialysate fluid carrying portion provided by the disposable cassette;

a sorbent cartridge for cleaning used dialysate flowing in the dialysate circuit;

a reservoir holding an initial supply of dialysate mixed from water and concentrate in the reservoir, wherein the dialysate exiting the sorbent cartridge enters the reservoir;

a reservoir pump in fluid communication with the dialysate circuit and the reservoir, the reservoir pump including a fluid carrying portion provided by the disposable cassette;

a supply of infusate; and

an infusate pump in fluid communication with the dialysate circuit and the supply of infusate.