# US 10,245,370 B2 · Renal failure therapy machines and methods including convective and diffusive clearance

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- Number: US 10,245,370 B2
- Document ID: US10245370B2
- Status: Granted
- Kind: B2
- Application number: 15/492,626
- Filed: 2017-04-20
- Published: 2017-08-03
- Granted: 2019-04-02
- Earliest claimed: 2003-11-05
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Baxter International Inc.; Baxter Healthcare SA
- Inventors: Thomas Kelly; Robert W. Childers; Don Busby; Rodolfo Roger; Waleed Mutasem El Sayyid; Shahid Din
- Web page: https://patentgrep.com/patent/US10245370B2

## CPC

- A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)}
- A61M 1/153: {the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- 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}
- A61M 1/15625: {the reservoirs acting as balance chambers}
- A61M 1/1563: {Details of incorporated filters}
- A61M 1/1565: {Details of valves}
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome}
- 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)}
- A61M 1/1629: {with integral heat exchanger}
- A61M 1/1633: {with more than one dialyser unit}
- A61M 1/1635: {with volume chamber balancing devices between used and fresh dialysis fluid}
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/166: {Heating (for sterilisation A61M1/1686)}
- A61M 1/1668: {Details of containers}
- A61M 1/167: {Flexible packaging for solid concentrates}
- A61M 1/1672: {using membrane filters, e.g. for sterilising the dialysate}
- A61M 1/1696: {with dialysate regeneration}
- A61M 1/267: {used for pumping}
- A61M 1/288: {Priming (priming in extracorporeal blood circuits A61M1/3643)}
- A61M 1/3401: {Cassettes therefor}
- A61M 1/341: {by measuring the filtrate rate or volume}
- A61M 1/3417: {using distinct filters for dialysis and ultra-filtration}
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3427: {back through the membrane, e.g. by inverted trans-membrane pressure [TMP]}
- A61M 1/3431: {upstream of the filter}
- A61M 1/3434: {with pre-dilution and post-dilution}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 1/3444: {in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir}
- A61M 1/3451: {the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal}
- A61M 1/3458: {having electrolytes not present in the dialysate}
- A61M 1/3465: {using dialysate as substitution fluid}
- A61M 1/3468: {using treated filtrate as substitution fluid}
- A61M 1/3472: {with treatment of the filtrate}
- A61M 1/36224: {with sensing means or components thereof}
- A61M 1/36225: {with blood pumping means or components thereof}
- 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}
- A61M 1/362265: {Details of valves}
- A61M 1/3624: {Level detectors; Level control}
- A61M 1/3626: {Gas bubble detectors}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3644: {Mode of operation}
- A61M 1/3646: {Expelling the residual body fluid after use, e.g. back to the body}
- A61M 1/3647: {with recirculation of the priming solution}
- A61M 1/3649: {using dialysate as priming or rinsing liquid}
- A61M 1/365: {through membranes, e.g. by inverted trans-membrane pressure [TMP]}
- A61M 1/3652: {using gas, e.g. air}
- A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections}
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 60/258: Piston pumps
- A61M 60/279: Peristaltic pumps, e.g. roller pumps
- A61M 60/37: Haemodialysis, haemofiltration or diafiltration
- A61M 60/43: using vacuum at the blood pump, e.g. to accelerate filling
- A61M 60/508: Electronic control means, e.g. for feedback regulation
- A61M 60/847: arranged in a cassette
- A61M 60/849: Disposable parts
- A61M 60/851: Valves
- A61M 1/1522: {the interface being evacuated interfaces to enhance contact}
- A61M 1/3486: {Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents}
- A61M 1/362223: {the interface being evacuated interfaces to enhance contact}
- A61M 2202/0413: Blood
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/127: with provisions for heating or cooling
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/15: Detection of leaks
- A61M 2205/18: with alarm
- A61M 2205/276: preventing unwanted use
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3393: by weighing the reservoir
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/75: with filters
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A renal failure therapy machine includes a blood cleaning filter, a dialysis fluid circuit including a balance chamber, the balance chamber including a fresh dialysis fluid compartment configured to send fresh dialysis fluid to the blood cleaning filter and a used dialysis fluid compartment configured to receive used dialysis fluid from the blood cleaning filter, a fresh dialysis fluid line in fluid communication with the fresh dialysis fluid compartment of the balance chamber and the blood cleaning filter, and a flow restrictor in fluid communication with the blood cleaning filter, the flow restrictor configured to cause fresh dialysis fluid delivered from the fresh dialysis fluid compartment, through the fresh dialysis fluid line, to the blood cleaning filter to be pressurized so that a first amount of the fresh dialysis fluid performs convective clearance and a second amount of the fresh dialysis fluid performs diffusive clearance.

## Claims

### Claim 1

A renal failure therapy machine comprising:
a blood cleaning filter;
a dialysis fluid circuit including a balance chamber, the balance chamber including a fresh dialysis fluid compartment configured to send fresh dialysis fluid to the blood cleaning filter and a used dialysis fluid compartment configured to receive used dialysis fluid from the blood cleaning filter;
a fresh dialysis fluid line in fluid communication with the fresh dialysis fluid compartment of the balance chamber and the blood cleaning filter; and
a flow restrictor in fluid communication with the blood cleaning filter, the flow restrictor configured to cause fresh dialysis fluid delivered from the fresh dialysis fluid compartment, through the fresh dialysis fluid line, to the blood cleaning filter to be pressurized so that a first amount of the fresh dialysis fluid performs convective clearance and a second amount of the fresh dialysis fluid performs diffusive clearance.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The renal failure therapy machine of claim 1, which includes a used dialysis fluid pump in fluid communication with the used dialysis fluid compartment and the blood cleaning filter, wherein used dialysis fluid pumped from the used dialysis fluid pump to the used dialysis fluid compartment causes the fresh dialysis fluid to be delivered from the fresh dialysis fluid compartment to the blood cleaning filter.

### Claim 4 (depends on 1)

The renal failure therapy machine of claim 1, wherein the flow restrictor is pneumatically actuated.

### Claim 5 (depends on 1)

The renal failure therapy machine of claim 1, wherein the flow restrictor includes a backpressure regulator.

### Claim 6 (depends on 1)

The renal failure therapy machine of claim 1, wherein the flow restrictor includes a variable orifice valve.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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.

### Claim 9

A renal failure therapy machine comprising:
a blood circuit including a blood cleaning filter;
a dialysis fluid circuit including a balance chamber, the balance chamber including a fresh dialysis fluid compartment configured to send fresh dialysis fluid to the blood cleaning filter and a used dialysis fluid compartment configured to receive used dialysis fluid from the blood cleaning filter;
a valve located along a fresh dialysis fluid pathway placing the fresh dialysis fluid compartment of the balance chamber into fluid communication with the blood cleaning filter, the valve enabling fresh dialysis fluid to flow selectively from the fresh dialysis fluid compartment of the balance chamber to the blood cleaning filter; and
a flow restrictor in fluid communication with the blood cleaning filter, the flow restrictor configured to cause fresh dialysis fluid pumped past the valve to the blood cleaning filter to be pressurized so that a first amount of the fresh dialysis fluid performs convective clearance and a second amount of the fresh dialysis fluid performs diffusive clearance.

### Claim 10 (depends on 9)

The renal failure therapy machine of claim 9, wherein the flow restrictor includes a variable pneumatic valve.

### Claim 11 (depends on 9)

The renal failure therapy machine of claim 9, wherein the flow restrictor includes a backpressure regulator.

### Claim 12 (depends on 9)

The renal failure therapy machine of claim 9, wherein the flow restrictor includes a variable orifice valve.

### Claim 13 (depends on 9)

The renal failure therapy machine of claim 9, which includes a disposable cassette, the disposable cassette including at least a portion of the dialysis fluid circuit.

### Claim 14 (depends on 9)

The renal failure therapy machine of claim 9, which includes a disposable cassette, the disposable cassette including at least a portion of the blood circuit.

### Claim 15 (depends on 9)

The renal failure therapy machine of claim 9, wherein the valve is a first valve and which includes a second valve located along a used dialysis fluid pathway placing the used dialysis fluid compartment in selective communication with the blood cleaning filter.

### Claim 16

A renal failure therapy method comprising:
delivering fresh dialysis fluid from a fresh dialysis fluid compartment of a balance chamber to a blood cleaning filter;
pumping used dialysis fluid from the blood cleaning filter to a used dialysis fluid compartment of the balance chamber;
restricting flow to cause a first amount of fresh dialysis fluid to be pressed through a membrane of the blood cleaning filter into an extracorporeal circuit so that the first amount of the fresh dialysis fluid performs convective clearance; and
using a second amount of the fresh dialysis fluid to cause the blood cleaning filter to perform diffusive clearance.

### Claim 17 (depends on 16)

The renal failure therapy method of claim 16, which includes pneumatically restricting flow to cause the fresh dialysis fluid to be pressed through the membrane.

### Claim 18 (depends on 16)

The renal failure therapy method of claim 16, the blood cleaning filter including a venous filter and an arterial filter, wherein restricting flow includes flowing the fresh dialysis fluid through a restriction placed between the venous filter and the arterial filter.

### Claim 19 (depends on 16)

The renal failure therapy method of claim 16, wherein pumping the used dialysis fluid causes the delivery of the fresh dialysis fluid from the fresh dialysis fluid compartment of the balance chamber to the blood cleaning filter.

### Claim 20 (depends on 16)

The renal failure therapy method of claim 16, which includes causing a second percentage of dialysis fluid performing convective clearance in a second treatment to be different from a first percentage in a first treatment.