Medical fluid pump valve integrity test methods and systems

• US 9,072,831 B2
• Filed: 09/30/2011
• Issued: 07/07/2015
• 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:
  US13/249,603
• Publication Number:
  US 20120022441A1
• Time in Patent Office: 1,376 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 valve integrity method for a medical fluid pump includes pumping fluid into the medical fluid pump while an outlet valve is closed and an inlet valve is open, closing the inlet valve while the outlet valve is closed, attempting to pump fluid out of the medical fluid pump while the inlet valve and the outlet valve are closed, and determining that at least one of the valves is leaking if a change in medical fluid volume within the medical fluid pump is detected.

Claims

1. A valve integrity method for a medical fluid pump placed in line with an inlet valve and an outlet valve, the method comprising:

(a) pumping fluid into the medical fluid pump while the outlet valve is closed and the inlet valve is open;

(b) closing the inlet valve while the outlet valve is closed;

(c) attempting to pump fluid out of the medical fluid pump while the inlet valve and the outlet valve are closed by applying a pressure that is less than a maximum possible pressure so as not to damage the medical fluid pump; and

(d) determining that at least one of the valves is leaking if a change in medical fluid volume within the medical fluid pump is detected.

2. The valve integrity method of claim 1, which includes using a volumetric balancing device to detect whether the volume change within the medical fluid pump occurs.

3. The valve integrity method of claim 1, which includes using a pressure volume relationship to detect whether the volume change within the medical fluid pump occurs.

4. The valve integrity method of claim 1, which includes performing (a) to (d) periodically throughout a medical fluid therapy.

5. The valve integrity method of claim 1, which includes performing (a) to (d) for a therapy selected from the group consisting of:

hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis and any combination thereof.

6. The valve integrity method of claim 1, which includes detecting whether a flexible membrane positioned in the medical fluid pump moves.

7. The valve integrity method of claim 1, which includes attempting to pump medical fluid out of a pump chamber via a pump actuator.

8. The valve integrity method of claim 1, which includes one of (i) issuing an alarm if the determination is a change in medical fluid volume, and (ii) stopping the medical fluid pump from pumping medical fluid if the determination is a change in medical fluid volume.

9. The valve integrity method of claim 1, which includes performing (a) to (d) at the beginning of a medical fluid therapy.

10. The valve integrity method of claim 1, which includes performing (a) to (d) on a plurality of medical fluid pumps of a machine, each of the plurality of medical fluid pumps including an inlet valve and an outlet valve.

11. A medical fluid machine comprising:

a medical fluid pump;

an inlet valve and an outlet valve each in fluid communication with the medical fluid pump;

a volume measuring device configured to detect a medical fluid volume within the medical fluid pump; and

a controller configured to (i) pump medical fluid into the medical fluid pump with the outlet valve closed and the inlet valve open, (ii) close the inlet valve while the outlet valve is closed;

(iii) attempt to pump medical fluid out of the medical fluid pump while the inlet valve and the outlet valve are closed by applying a pressure that is less than a maximum possible pressure so as not to damage the medical fluid pump; and

(iv) determine, via the volume measuring device, that at least one of the valves is leaking if a change in medical fluid volume within the medical fluid pump is detected.

12. The medical fluid machine of claim 11, wherein the volume measuring device includes a volumetric reference chamber and an ideal gas law relationship manipulated by the controller.

13. The medical fluid machine of claim 11, wherein the volume measuring device includes a volumetric balancing device.

14. The medical fluid machine of claim 11, wherein the medical fluid machine is constructed to perform a therapy selected from the group consisting of:

hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis and any combination thereof.

15. The medical fluid machine of claim 11, wherein the medical fluid pump includes a pump chamber and a flexible membrane positioned within the pump chamber.

16. The medical fluid machine of claim 11, which includes a pump actuator, and the controller is configured to attempt to pump medical fluid out of the pump chamber via the pump actuator.

17. The medical fluid machine of claim 11, wherein the controller is configured to one of (i) issue an alarm if the determination is a change in medical fluid volume, and (ii) stop the medical fluid pump from pumping if the determination is a change in medical fluid volume.

18. The medical fluid machine of claim 11, wherein the controller is configured to perform (i) to (iv) at the beginning of a medical fluid therapy.

19. The medical fluid machine of claim 11, wherein the controller is configured to perform (i) to (iv) periodically throughout a medical fluid therapy.

20. The medical fluid machine of claim 11, which includes a plurality of medical fluid pumps each including an inlet valve and an outlet valve, wherein the controller is configured to perform (i) to (iv) on the plurality of medical fluid pumps.