# US 9,039,648 B2 · Dialysis system with enhanced features

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- Number: US 9,039,648 B2
- Document ID: US9039648B2
- Status: Granted
- Kind: B2
- Application number: 12/885,082
- Filed: 2010-09-17
- Published: 2011-01-06
- Granted: 2015-05-26
- Earliest claimed: 2003-11-05
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Thomas Kelly; Robert W. Childers; Don Busby; Rodolfo Roger; Waleed Mutasem El Sayyid; Shahid Din
- Inventors: Thomas Kelly; Robert W. Childers; Don Busby; Rodolfo Roger; Waleed Mutasem El Sayyid; Shahid Din
- Web page: https://patentgrep.com/patent/US9039648B2

## 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 dialysis system includes a dialysis fluid cassette-based membrane blood pump; a dialyzer in fluid communication with the blood pump: first and second dialysis fluid cassette-based balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment; a dialysis fluid cassette-based fresh dialysis fluid membrane pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers; a dialysis fluid cassette-based spent dialysis fluid membrane pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers; and arterial and venous lines in fluid communication with the dialyzer for patient connection, the arterial and venous lines each including a contact used for electrically detecting a patient access disconnection.

## Claims

### Claim 1

A dialysis system comprising:
a cassette-based membrane blood pump;
a dialyzer in fluid communication with the blood pump;
first and second dialysis fluid cassette-based balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment;
a cassette-based fresh dialysis fluid membrane pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers;
a cassette-based spent dialysis fluid membrane pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers; and
arterial and venous lines in fluid communication with the dialyzer for patient connection, the arterial and venous lines each including a contact used for electrically detecting a patient access disconnection; and
wherein
(i) the fresh dialysis fluid compartment of the first cassette-based balance chamber and the fresh dialysis fluid compartment of the second cassette-based balance chamber each have a single port for (a) receiving dialysis fluid from the cassette-based fresh dialysis fluid membrane pump, and (b) delivering fresh dialysis fluid from the respective fresh dialysis fluid compartment, and
(ii) the spent dialysis fluid compartment of the first cassette-based balance chamber and the spent dialysis fluid compartment of the second cassette-based balance chamber each have a single port for (a) receiving dialysis fluid from the cassette-based spent dialysis fluid membrane pump, and (b) delivering spent dialysis fluid from the respective spent dialysis fluid compartment.

### Claim 2 (depends on 1)

The dialysis system of claim 1, which includes an access disconnection sensor operable with the arterial and venous contacts for detecting a patient access disconnection.

### Claim 3 (depends on 1)

The dialysis system of claim 1, which is configured to stop the blood pump upon detecting the patient access disconnection.

### Claim 4 (depends on 1)

The dialysis system of claim 1, which is configured to use the arterial and venous contacts to sense a change in electrical impedance to detect the patient access disconnection.

### Claim 5 (depends on 1)

The dialysis system of claim 1, which is configured to close at least one valve upon detecting the patient access disconnection.

### Claim 6 (depends on 1)

The dialysis system of claim 1, wherein the dialyzer is connected to a disposable cassette, and which includes at least one blood valve having a blood containing portion located in the disposable cassette.

### Claim 7 (depends on 6)

The dialysis system of claim 6, wherein the arterial and venous lines are in fluid communication with the dialyzer via the disposable cassette.

### Claim 8 (depends on 6)

The dialysis system of claim 6, wherein the fresh compartments of the first and second balance chambers are in fluid connection with the dialyzer via the disposable cassette.

### Claim 9 (depends on 1)

The dialysis system of claim 1, wherein the electrical contact in the venous line is located between all other venous line components and the venous line patient access.

### Claim 10 (depends on 1)

The dialysis system of claim 1, wherein the electrical contact in the arterial line is located between all other arterial line components and the arterial line patient access.

### Claim 11

A dialysis system comprising:
a blood pump;
a dialyzer in fluid communication with the blood pump;
first and second dialysis fluid balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment;
a fresh dialysis fluid pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers;
a spent dialysis fluid pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers; and
wherein
(i) the fresh dialysis fluid compartment of the first balance chamber and the fresh dialysis fluid compartment of the second balance chamber each have a single port for (a) receiving dialysis fluid from the fresh dialysis fluid pump, and (b) delivering fresh dialysis fluid from the respective fresh dialysis fluid compartment, and
(ii) the spent dialysis fluid compartment of the first balance chamber and the spent dialysis fluid compartment of the second balance chamber each have a single port for (a) receiving dialysis fluid from the spent dialysis fluid pump, and (b) delivering spent dialysis fluid from the respective spent dialysis fluid compartment.

### Claim 12 (depends on 11)

The dialysis system of claim 11, wherein at least one of the blood pump, the fresh dialysis fluid pump, or the spent dialysis fluid pump is cassette-based.

### Claim 13 (depends on 11)

The dialysis system of claim 11, wherein at least one of the first or second dialysis fluid balance chambers is cassette-based.

### Claim 14

A dialysis system comprising:
a blood pump;
a dialyzer in fluid communication with the blood pump;
first and second dialysis fluid balance chambers each having (i) a fresh dialysis fluid compartment in fluid communication with the dialyzer and (ii) a spent dialysis fluid compartment;
a fresh dialysis fluid pump in fluid communication with the fresh dialysis fluid compartments of the first and second balance chambers;
a spent dialysis fluid pump in fluid communication with the dialyzer and the spent dialysis fluid compartments of the first and second balance chambers; and
wherein
(i) the fresh dialysis fluid compartment of the first balance chamber has a single port for (a) receiving dialysis fluid from the fresh dialysis fluid pump, and (b) delivering fresh dialysis fluid from the fresh dialysis fluid compartment of the first balance chamber,
(ii) the spent dialysis fluid compartment of the first balance chamber has a single port for (a) receiving dialysis fluid from the spent dialysis fluid pump, and (b) delivering spent dialysis fluid from the spent dialysis fluid compartment of the first balance chamber,
(iii) the fresh dialysis fluid compartment of the second balance chamber has a single port for (a) receiving dialysis fluid from the fresh dialysis fluid pump, and (b) delivering fresh dialysis fluid from the fresh dialysis fluid compartment of the second balance chamber, and
(iv) the spent dialysis fluid compartment of the second balance chamber has a single port for (a) receiving dialysis fluid from the spent dialysis fluid pump, and (b) delivering spent dialysis fluid from the spent dialysis fluid compartment of the second balance chamber.

### Claim 15 (depends on 14)

The dialysis system of claim 14, wherein at least one of the blood pump, the fresh dialysis fluid pump, or the spent dialysis fluid pump is cassette-based.

### Claim 16 (depends on 14)

The dialysis system of claim 14, wherein at least one of the first or second dialysis fluid balance chambers is cassette-based.