Dialysis system including disposable cassette

• US 9,168,333 B2
• Filed: 10/10/2014
• Issued: 10/27/2015
• 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 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:
  US14/511,908
• Publication Number:
  US 20150027936A1
• Time in Patent Office: 382 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 machine having a pump actuator, a valve actuator and a sorbent device, and a disposable cassette including (i) a housing having a dialyzer inlet port, a dialyzer outlet port, a pump portion configured to operate with the pump actuator, a valve portion configured to operate with the valve actuator, a venous port, and an arterial port, (ii) at least one dialyzer in fluid communication with the housing, the at least one dialyzer including a dialysate inlet, and a dialysate outlet; (iii) an arterial line for connecting to a patient, the arterial line connected to and extending externally from the arterial port of the housing; (iv) a venous line for connecting to a patient, the venous line connected to and extending externally from the venous port of the housing; and (v) first and second dialysate fluid connections in fluid communication with the sorbent device.

Claims

1. A dialysis system comprising:

a dialysis machine including

a blood pump actuator,

a dialysate pump actuator,

a blood valve actuator,

a dialysate valve actuator, and

a pressure sensor;

a sorbent device;

a disposable cassette including

a dedicated dialyzer inlet port,

a dedicated dialyzer outlet port,

a blood pump portion operable with the blood pump actuator,

a dialysate pump portion operable with the dialysate pump actuator,

a blood valve portion operable with the blood valve actuator,

a dialysate valve portion operable with the dialysate valve actuator,

a pressure sensor portion operable with the pressure sensor, and

a recirculation line in fluid communication with the sorbent device;

a dialyzer including

a dialysate inlet, and

a dialysate outlet;

a first dialysate fluid connection extending from the dedicated dialyzer inlet port of the disposable cassette to the dialysate inlet of the dialyzer; and

a second dialysate fluid connection extending from the dedicated dialyzer outlet port of the disposable cassette to the dialysate outlet of the dialyzer.

2. The dialysis system of claim 1, wherein the dialysis machine includes a blood leak detector, and wherein the disposable cassette includes a blood leak detector portion operable with the blood leak detector.

3. The dialysis system of claim 1, wherein the dialysis machine includes a conductivity sensor, and wherein the disposable cassette includes a conductivity sensor portion operable with the conductivity sensor.

4. The dialysis system of claim 1, which includes a branch line in fluid communication with the recirculation line and the second dialysate fluid connection.

5. The dialysis system of claim 1, wherein at least one of the blood pump actuator or the dialysate pump actuator includes a peristaltic pump actuator, and at least one of the blood pump portion or the dialysate pump portion of the disposable cassette includes a peristaltic pumping tube.

6. The dialysis system of claim 1, which includes an infusate source in fluid communication with the sorbent device, the infusate source located downstream of the sorbent device.

7. The dialysis system of claim 1, wherein at least one of (i) the blood valve actuator is mechanically actuated, and (ii) the dialysate valve actuator is mechanically actuated.

8. The dialysis system of claim 1, wherein at least one of (i) the blood pump actuator is pneumatically actuated, or (ii) the dialysate pump actuator is pneumatically actuated.

9. A dialysis system comprising:

a dialysis machine including a pump actuator, a valve actuator and a sorbent device; and

a disposable cassette operable with the dialysis machine, the disposable cassette including

(i) a housing including

a dialyzer inlet port,

a dialyzer outlet port,

a pump portion configured to operate with the pump actuator,

a valve portion configured to operate with the valve actuator,

a venous port, and

an arterial port,

(ii) at least one dialyzer in fluid communication with the housing, the at least one dialyzer including

a dialysate inlet, and

a dialysate outlet;

(iii) an arterial line for connecting to a patient, the arterial line connected to and extending externally from the arterial port of the housing;

(iv) a venous line for connecting to the patient, the venous line connected to and extending externally from the venous port of the housing;

(v) a first dialysate fluid connection connected to and extending from the dialyzer inlet port of the disposable cassette to the dialysate inlet of the at least one dialyzer, the first dialysate fluid connection in fluid communication with the sorbent device; and

(vi) a second dialysate fluid connection connected to and extending from the dialyzer outlet port of the disposable cassette to the dialysate outlet of the at least one dialyzer, the second dialysate fluid connection in fluid communication with the sorbent device.

10. The dialysis system of claim 9, which includes at least one blood connection extending externally from the disposable cassette housing to the at least one dialyzer.

11. The dialysis system of claim 9, which includes an infusate located downstream of the sorbent device.

12. The dialysis system of claim 9, which includes (i) a dialysate fill line extending from a source of dialysate to the housing of the disposable cassette, and (ii) a drain line extending from the housing of the disposable cassette.

13. The dialysis system of claim 12, wherein the source of dialysate includes a container for holding dialysate made from water and concentrate.

14. The dialysis system of claim 9, which includes at least one of (i) the dialysis machine including a pressure sensor and the housing of the disposable cassette including a pressure sensor portion operable with the pressure sensor, (ii) the dialysis machine including a blood leak detector and the housing of the disposable cassette including a blood leak detector portion operable with the blood leak detector, (iii) the dialysis machine including a conductivity sensor and the housing of the disposable cassette including a conductivity sensor portion operable with the conductivity sensor.

16. The dialysis system of claim 9, wherein the housing of the disposable cassette further includes an air collection chamber.

15. The dialysis system 9, which includes a branch line in fluid communication with the second dialysate fluid connection and the sorbent device.

17. A dialysis system comprising:

a dialysis machine including at least one pump actuator, at least one valve actuator, at least one sensor and a sorbent device; and

a disposable pumping cassette operable with the dialysis machine, the disposable pumping cassette including

at least one senor portion operable with the at least one sensor,

at least one pumping portion operable with the at least one pump actuator, at least one valve portion operable with the at least one valve actuator,

a first fluid connection in communication with a dialysate inlet of a dialyzer; and

a second dialysate fluid connection in communication with a dialysate outlet of the dialyzer; and

a recirculation line in fluid communication with the second dialysate fluid connection and the sorbent device.

18. The dialysis system of claim 17, wherein the recirculation line branches off of the second dialysate fluid connection.

19. The dialysis system of claim 17, wherein the at least one sensor of the dialysis machine includes at least one of a pressure sensor, a blood leak detector or a conductivity sensor.

20. The dialysis system of claim 17, which includes an air detector located in a blood line.