Renal failure therapy machines and methods including convective and diffusive clearance

• US 9,642,961 B2
• Filed: 12/21/2015
• Issued: 05/09/2017
• 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 Musatem, Din, Shahid
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/976,773
• Publication Number:
  US 20160106901A1
• Time in Patent Office: 505 Days
• Field of Search: 604 401- 616, 210616, 21032171
• 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 renal failure therapy machine includes a blood cleaning filter, a sorbent device configured to regenerate used therapy fluid from the blood cleaning filter, a therapy fluid pump configured to pump regenerated therapy fluid from the sorbent device back to the blood cleaning filter, and a flow restrictor in fluid communication with the blood cleaning filter, the therapy fluid pump and the sorbent device, the flow restrictor configured to cause regenerated therapy fluid pumped by the therapy fluid pump from the sorbent device to the blood cleaning filter to be pressurized so that a first amount of the regenerated therapy fluid performs convective clearance and a second amount of the regenerated therapy fluid performs diffusive clearance.

Claims

1. A renal failure therapy machine comprising:

a blood cleaning filter;

a sorbent device configured to regenerate used therapy fluid from the blood cleaning filter;

a therapy fluid pump configured to pump regenerated therapy fluid from the sorbent device back to the blood cleaning filter; and

a flow restrictor in fluid communication with the blood cleaning filter, the therapy fluid pump and the sorbent device, the flow restrictor configured to cause regenerated therapy fluid pumped by the therapy fluid pump from the sorbent device to the blood cleaning filter to be pressurized so that a first amount of the regenerated therapy fluid performs convective clearance and a second amount of the regenerated therapy fluid performs diffusive clearance.

2. The renal failure therapy machine of claim 1, which operates the flow restrictor to cause the regenerated therapy fluid to be pressurized so that at least ten percent of the regenerated therapy fluid performs convective clearance and at least a substantial amount of remaining regenerated therapy fluid performs diffusive clearance.

3. The renal failure therapy machine of claim 1, wherein the sorbent device includes a sorbent cartridge downstream from the blood cleaning filter, the sorbent cartridge including at least one of:

(i) an activated charcoal filter;

(ii) a sorbent exchange;

(iii) a chemical cleaner;

(iv) a chemical exchange;

(v) a biological cleanser;

(vi) a binding adsorption agent;

(vii) an enzymatic reaction agent; and

(viii) a mechanical cleaner.

4. The renal failure therapy machine of claim 1, wherein the flow restrictor includes at least one of:

(i) a backpressure regulator;

or (ii) a variable orifice valve.

5. The renal failure therapy machine of claim 1, wherein the flow restrictor is configured to vary a percentage of the regenerated therapy fluid used for convective versus diffusive clearance during treatment.

6. The renal failure therapy machine of claim 1, wherein the blood cleaning filter includes a venous filter and an arterial filter, and wherein the flow restrictor is located between the venous filter and the arterial filter.

7. The renal failure therapy machine of claim 1, which is configured to cause a percentage of the regenerated therapy fluid performing convective clearance to be different in a second treatment from the percentage in a first treatment.

8. A renal failure therapy method comprising:

placing a sorbent device in fluid communication with a blood cleaning filter;

regenerating used therapy fluid from the blood cleaning filter with the sorbent device;

causing the regenerated therapy fluid to flow back to the blood cleaning filter;

restricting flow to cause the regenerated therapy fluid to be pressed through a membrane of the blood cleaning filter into an extracorporeal circuit so that a first amount of the regenerated therapy fluid to the blood cleaning filter performs convective clearance; and

using the blood cleaning filter to cause a second amount of the regenerated therapy fluid to the blood cleaning filter to perform diffusive clearance.

9. The renal failure therapy method of claim 8, which includes pneumatically restricting flow to cause the regenerated therapy fluid to be pressed through the membrane.

10. The renal failure therapy method of claim 8, the blood cleaning filter including a venous filter and an arterial filter, wherein restricting flow includes flowing the regenerated therapy fluid through a restriction placed between the venous filter and the arterial filter.

11. The renal failure therapy method of claim 10, wherein the performing of diffusive clearance occurs across a membrane of the venous filter and a membrane of the arterial filter.

12. The renal failure therapy method of claim 8, which includes causing at least ten percent of the regenerated therapy fluid returned to the blood cleaning filter to perform convective clearance and a remaining amount of the regenerated and returned therapy fluid to the blood cleaning filter to perform diffusive clearance.

13. The renal failure therapy method of claim 8, which includes causing a percentage of therapy fluid performing convective clearance in a second treatment to be different from the percentage in a first treatment.

14. A renal failure therapy machine comprising:

a blood circuit including a blood cleaning filter;

a therapy fluid circuit including a balance chamber, the balance chamber including a fresh therapy fluid compartment configured to send fresh therapy fluid to the blood cleaning filter and a used therapy fluid compartment configured to receive used therapy fluid from the blood cleaning filter;

a first pump configured to pump fresh therapy fluid to the fresh therapy fluid compartment of the balance chamber;

a second pump configured to pump used therapy fluid to the used therapy fluid compartment of the balance chamber; and

a pneumatically actuated flow restrictor in fluid communication with the balance chamber and the blood cleaning filter, the flow restrictor pneumatically actuated to cause fresh therapy fluid traveling from the fresh therapy fluid compartment of the balance chamber to the blood cleaning filter to be pressurized so that a first amount of the fresh therapy fluid performs convective clearance and a second amount of the fresh therapy fluid performs diffusive clearance.

15. The renal failure therapy machine of claim 14, wherein the therapy fluid circuit includes a sorbent device configured to regenerate used therapy fluid.

16. The renal failure therapy machine of claim 14, which includes a disposable cassette, the disposable cassette including at least a portion of the therapy fluid circuit.

17. The renal failure therapy machine of claim 14, which includes a disposable cassette, the disposable cassette including at least a portion of the blood circuit.

18. The renal failure therapy machine of claim 14, wherein the flow restrictor includes a variable pneumatic valve.

19. The renal failure therapy machine of claim 14, wherein the blood cleaning filter includes a venous filter and an arterial filter, and the flow restrictor is located between the venous filter and the arterial filter.

20. The renal failure therapy machine of claim 14, wherein the first and second pumps are pneumatically actuated membrane pumps.