Dialysis system including cassette with pumping tubes

• US 10,293,096 B2
• Filed: 07/08/2016
• Issued: 05/21/2019
• 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:
  US15/205,268
• Publication Number:
  US 20160317732A1
• Time in Patent Office: 1,047 Days
• Field of Search: 604 401- 616
• 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 includes a blood treatment machine, a blood pump housed by the blood treatment machine, a first dialysate pump housed by the blood treatment machine, a second dialysate pump housed by the blood treatment machine; and a fluid cassette including an upper portion and a lower portion. The fluid cassette further includes a blood pumping tube extending from the upper portion to the lower portion of the fluid cassette, a first dialysate pumping tube extending from the upper portion to the lower portion of the fluid cassette, and a second dialysate pumping tube extending from the upper portion to the lower portion of the fluid cassette.

Claims

1. A hemodialysis system comprising:

a blood treatment machine;

a blood pump housed by the blood treatment machine;

a first dialysate pump housed by the blood treatment machine;

a second dialysate pump housed by the blood treatment machine; and

a fluid cassette including an upper portion and a lower portion, the fluid cassette further including;

a blood pumping tube extending linearly from the upper portion to the lower portion of the fluid cassette such that at least a portion of the blood pumping tube is exposed to the outside of the fluid cassette between the upper portion and the lower portion, the blood pumping tube actuated by the blood pump at the exposed portion,

a first dialysate pumping tube extending linearly from the upper portion to the lower portion of the fluid cassette such that at least a portion of the first dialysate pumping tube is exposed to the outside of the fluid cassette between the upper portion and the lower portion, the first dialysate pumping tube actuated by the first dialysate pump at the exposed portion, and

a second dialysate pumping tube extending linearly from the upper portion to the lower portion of the fluid cassette such that at least a portion of the second dialysate pumping tube is exposed to the outside of the fluid cassette between the upper portion and the lower portion, the second dialysate pumping tube actuated by the second dialysate pump at the exposed portion.

2. The hemodialysis system of claim 1, wherein the upper and lower portions of the fluid cassette are horizontal portions when the fluid cassette is inserted into the blood treatment machine, the horizontal portions connected via a vertical portion.

3. The hemodialysis system of claim 2, wherein the blood pumping tube, the first dialysate pumping tube and the second dialysate pumping tube are disposed to the left or right of the vertical portion when the fluid cassette is inserted into the blood treatment machine.

4. The hemodialysis system of claim 1, wherein the fluid cassette includes at least one of:

(i) a first pressure sensing portion located downstream of the blood pumping tube;

or (ii) a second pressure sensing portion located upstream of the blood pumping tube.

5. The hemodialysis system of claim 1, wherein the fluid cassette includes a first pressure sensing portion located downstream of the blood pumping tube and a second pressure sensing portion located upstream of the blood pumping tube.

6. The hemodialysis system of claim 1, wherein the upper and lower portions of the fluid cassette each include plural fluid ports for sealingly connecting to the blood pumping tube, the first dialysate pumping tube or the second dialysate pumping tube.

7. The hemodialysis system of claim 1, wherein the upper and lower portions of the fluid cassette each include at least one valve portion configured to stop or permit fluid flow to or from at least one of the blood pumping tube, the first dialysate pumping tube or the second dialysate pumping tube.

8. The hemodialysis system of claim 1, wherein the fluid cassette includes a fluid heating section located between the upper and lower portions of the fluid cassette.

9. The hemodialysis system of claim 1, wherein at least one of the upper and lower portions of the fluid cassette includes a blood leak detection section positioned and arranged to enable blood to be detected in dialysate pumped through one of the first or second dialysate pumping tubes.

10. The hemodialysis system of claim 1, which includes an air separation structure between the upper and lower portions of the fluid cassette that creates an air/fluid interface.

11. A hemodialysis system comprising:

a blood treatment machine;

a blood pump housed by the blood treatment machine;

a first dialysate pump housed by the blood treatment machine;

a second dialysate pump housed by the blood treatment machine; and

a fluid cassette configured to be inserted into the blood treatment machine in a vertical configuration with an upper portion of the fluid cassette located above a lower portion of the fluid cassette, the fluid cassette including;

a blood pumping tube extending vertically from the upper portion to the lower portion of the fluid cassette, at least a portion of the blood pumping tube exposed outside of the fluid cassette and actuated by the blood pump,

a first dialysate pumping tube extending vertically from the upper portion to the lower portion of the fluid cassette, at least a portion of the first dialysate pumping tube exposed outside of the fluid cassette and actuated by the first dialysate pump, and

a second dialysate pumping tube extending vertically from the upper portion to the lower portion of the fluid cassette, at least a portion of the second dialysate pumping tube exposed outside of the fluid cassette and actuated by the second dialysate pump.

12. The hemodialysis system of claim 11, wherein the upper and lower portions of the fluid cassette are horizontal portions when the fluid cassette is inserted into the blood treatment machine, the horizontal portions connected via a vertical portion.

13. The hemodialysis system of claim 12, wherein the blood pumping tube, the first dialysate pumping tube and the second dialysate pumping tube are disposed to the left or right of the vertical portion when the fluid cassette is inserted into the blood treatment machine.

14. The hemodialysis system of claim 11, which includes an air separation structure located between the upper and lower portions of the fluid cassette, the air separation structure creating an air/fluid interface.

15. The hemodialysis system of claim 11, wherein the upper and lower portions of the fluid cassette each include at least one valve portion configured to stop or permit fluid flow to or from at least one of the blood pumping tube, the first dialysate pumping tube or the second dialysate pumping tube.

16. The hemodialysis system of claim 11, wherein the fluid cassette includes a first pressure sensing portion located downstream of the blood pumping tube and a second pressure sensing portion located upstream of the blood pumping tube.

17. A hemodialysis system comprising:

a blood treatment machine;

a blood pump housed by the blood treatment machine;

a first dialysate pump housed by the blood treatment machine;

a second dialysate pump housed by the blood treatment machine; and

a fluid cassette including;

a blood pumping tube extending linearly within the fluid cassette, at least a portion of the linearly extending blood pumping tube exposed outside the fluid cassette for actuation by the blood pump,

a first dialysate pumping tube extending linearly within the fluid cassette, at least a portion of the first linearly extending dialysate pumping tube exposed outside the fluid cassette for actuation by the first dialysate pump,

a second dialysate pumping tube extending linearly within the fluid cassette, at least a portion of the second linearly extending dialysate pumping tube exposed outside the fluid cassette for actuation by the second dialysate pump,

a first pressure sensing portion located downstream of the blood pumping tube, and

a second pressure sensing portion located upstream of the blood pumping tube.

18. The hemodialysis system of claim 17, wherein at least one of the first pressure sensing portion or the second pressure sensing portion is located along an axis extending through a linear direction of the blood pumping tube.

19. The hemodialysis system of claim 17, wherein the fluid cassette is configured and arranged such that when the cassette is inserted into the blood treatment machine, the blood pumping tube, the first dialysate pumping tube and the second dialysate pumping tube extend vertically linearly.

20. The hemodialysis system of claim 17, wherein at least one of:

(i) the at least a portion of the blood pumping tube is exposed to the outside of the fluid cassette between the upper and lower portion of the fluid cassette;

(ii) the at least a portion of the first dialysate pumping tube is exposed to the outside of the fluid cassette between the upper and lower portion of the fluid cassette;

or (iii) the at least a portion of the second dialysate pumping tube is exposed to the outside of the fluid cassette between the upper and lower portion of the fluid cassette.

21. The hemodialysis system of claim 17, wherein the upper and lower portions of the fluid cassette each include plural fluid ports for sealingly connecting to the blood pumping tube, the first dialysate pumping tube or the second dialysate pumping tube.

22. The hemodialysis system of claim 17, which includes an air separation structure located between the upper and lower portions of the fluid cassette, the air separation structure creating an air/fluid interface.