# US 10,245,369 B2 · Systems and methods for priming hemodialysis using dialysis fluid

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- Number: US 10,245,369 B2
- Document ID: US10245369B2
- Status: Granted
- Kind: B2
- Application number: 15/163,128
- Filed: 2016-05-24
- Published: 2016-09-15
- Granted: 2019-04-02
- Earliest claimed: 2003-11-05
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Baxter International Inc.; Baxter Healthcare S.A.
- Inventors: Thomas Kelly; Robert W. Childers; Don Busby; Rodolfo Roger; Waleed Mutasem El Sayyid; Shahid Din
- Web page: https://patentgrep.com/patent/US10245369B2

## 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 method for priming a hemodialysis treatment includes: providing a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit; placing a dialyzer in fluid communication with the dialysate circuit via a to-dialyzer dialysate line and a from-dialyzer dialysate line; placing the dialyzer in fluid communication with the blood circuit via an arterial blood line and a venous blood line; placing a source of dialysis fluid in fluid communication with the dialyzer; priming the dialysate circuit with dialysis fluid from the source while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and priming the blood circuit with dialysis fluid from the source by actuating at least one valve provided by the disposable cassette.

## Claims

### Claim 1

A method for priming a hemodialysis treatment comprising:
providing a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit;
placing a dialyzer in fluid communication with the dialysate circuit via a to-dialyzer dialysate line and a from-dialyzer dialysate line;
placing the dialyzer in fluid communication with the blood circuit via an arterial blood line and a venous blood line;
placing a source of dialysis fluid in fluid communication with the dialyzer;
priming the dialysate circuit with dialysis fluid from the source while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and
priming the blood circuit with dialysis fluid from the source by actuating at least one valve provided by the disposable cassette.

### Claim 2 (depends on 1)

The method of claim 1, wherein priming the blood circuit includes reversing a blood pump at least one time.

### Claim 3 (depends on 2)

The method of claim 2, which includes reversing the blood pump after a drip chamber is filled with fluid.

### Claim 4 (depends on 1)

The method of claim 1, wherein priming the blood circuit includes connecting patient ends of the arterial blood line and the venous blood line together.

### Claim 5 (depends on 1)

The method of claim 1, which includes actuating at least one valve in the blood circuit to prime the blood circuit.

### Claim 6 (depends on 1)

The method of claim 1, wherein priming the blood circuit includes directing the dialysis fluid at one time in a first direction away from the dialyzer and at another time in a second direction towards the dialyzer.

### Claim 7 (depends on 1)

The method of claim 1, wherein priming the blood circuit includes directing the dialysis fluid at one time in a treatment operation direction and at another time in a reverse of the treatment operation direction.

### Claim 8 (depends on 1)

The method of claim 1, wherein priming the blood circuit includes pumping the dialysis fluid through the dialyzer.

### Claim 9 (depends on 1)

A dialysis machine configured and arranged to perform the method of claim 1.

### Claim 10

A method for priming a hemodialysis treatment comprising:
providing a sorbent cartridge for cleaning used dialysis fluid returning from a dialyzer;
preparing a batch of dialysis fluid in a quantity commensurate with being recycled through the sorbent cartridge multiple times;
priming a dialysate circuit in fluid communication with the dialyzer using the batch of dialysis fluid, while both a to-dialyzer dialysate line and a from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and
priming a blood circuit in fluid communication with the dialyzer using the batch of dialysis fluid.

### Claim 11 (depends on 10)

The method of claim 10, wherein preparing the batch of dialysis fluid includes mixing water and concentrate.

### Claim 12 (depends on 10)

The method of claim 10, wherein priming the blood circuit includes pumping dialysis fluid from the batch of dialysis fluid through the dialyzer.

### Claim 13 (depends on 10)

The method of claim 10, wherein priming the blood circuit includes connecting patient ends of an arterial blood line connected to the blood circuit and a venous blood line connected to the blood circuit together.

### Claim 14 (depends on 10)

A dialysis machine configured and arranged to perform the method of claim 10.

### Claim 15

A dialysis system comprising:
a dialyzer;
a disposable cassette including at least a portion of a dialysate circuit and at least a portion of a blood circuit, the dialysate circuit in fluid communication with the dialyzer via a to-dialyzer dialysate line and a from-dialyzer dialysate line, the blood circuit in fluid communication with the dialyzer via an arterial blood line and a venous blood line;
a source of dialysis fluid in fluid communication with the dialyzer;
at least one dialysis fluid pump configured to pump dialysis fluid from the source of dialysis fluid through the dialysate circuit;
at least one blood pump configured to pump blood from a patient through the blood circuit; and
at least one processor configured to operate a sequence in which (i) the dialysate circuit is primed with dialysis fluid from the source of dialysis fluid while both the to-dialyzer dialysate line and the from-dialyzer dialysate line are connected at their dialyzer ends to the dialyzer; and
(ii) the blood circuit is primed with dialysis fluid from the source of dialysis fluid by actuating at least one valve provided by the disposable cassette.

### Claim 16 (depends on 15)

The dialysis system of claim 15, wherein the source of dialysis fluid includes regenerated dialysis fluid from a sorbent cartridge.

### Claim 17 (depends on 15)

The dialysis system of claim 15, wherein the at least one processor reverses the at least one blood pump at least one time to prime the blood circuit.

### Claim 18 (depends on 15)

The dialysis system of claim 15, wherein the at least one valve is located in the portion of the blood circuit included in the disposable cassette.

### Claim 19 (depends on 15)

The dialysis system of claim 15, wherein the at least one valve is in fluid communication with the arterial blood line.

### Claim 20 (depends on 15)

The dialysis system of claim 15, wherein the at least one processor is configured to prime the blood circuit with patient ends of the arterial blood line and the venous blood line connected together.
