# US 11,439,738 B2 · Methods and Systems for fluid balancing in a dialysis system

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- Number: US 11,439,738 B2
- Document ID: US11439738B2
- Status: Granted
- Kind: B2
- Application number: 17/007,074
- Filed: 2020-08-31
- Published: 2020-12-24
- Granted: 2022-09-13
- Earliest claimed: 2007-11-29
- Assignees: Fresenius Medical Care Holdings, Inc.
- Applicants: Fresenius Medical Care Holdings, Inc.
- Inventors: Thomas Patrick Robinson; Charles E. Clemens; David Jacob Mishelevich; James Roswell Braig; Barry Neil Fulkerson; Daniele Ghidoli; Russell Thomas Joseph
- Web page: https://patentgrep.com/patent/US11439738B2

## CPC

- A61M 1/3417: {using distinct filters for dialysis and ultra-filtration}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/156: {Constructional details of the cassette, e.g. specific details on material or shape}
- A61M 1/1562: {Details of incorporated reservoirs}
- 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 1/1621: {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 1/1696: {with dialysate regeneration}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3403: {Regulation parameters}
- A61M 1/36224: {with sensing means or components thereof}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/36226: {Constructional details of cassettes, e.g. specific details on material or shape}
- A61M 1/362265: {Details of valves}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- A61M 39/08: Tubes; Storage means specially adapted therefor
- A61M 2202/0413: Blood
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/126: with incorporated membrane filters
- A61M 2205/128: with incorporated valves
- A61M 2205/3313: used specific wavelengths
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/75: with filters
- A61M 2209/00: Ancillary equipment
- Y10T 137/85938: Non-valved flow dividers
- 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)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

An extracorporeal blood processing system comprises a plastic molded compact manifold that supports a plurality of molded blood and dialysate fluidic pathways along with a plurality of relevant sensors, valves and pumps. A disposable dialyzer is connected to the molded manifold to complete the blood circuit of the system. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine.

## Claims

### Claim 1

A dialysis system configured to balance a first amount of fluid that is removed from a patient with a second amount of fluid that is delivered to the patient during a dialysis session, wherein the dialysis system comprises:
a dialyzer having a dialysate side and a blood side, wherein the dialysate side and blood side are separated by a material;
a blood circuit wherein the blood circuit directs blood from a patient, through the blood side of the dialyzer, and back to the patient;
a dialysate circuit wherein the dialysate circuit directs dialysate to the patient through the dialysate side of the dialyzer and wherein the dialysate circuit comprises:
a fluid reservoir configured to store regenerated dialysate;
a first dialysate pump configured to draw spent dialysate from the dialyzer;
a second dialysate pump configured to draw the regenerated dialysate from the fluid reservoir;
a third pump configured to draw waste fluid from the dialysate circuit;
a first valve configured to direct a first amount of spent dialysate to a first channel of the first dialysate pump and a second amount of spent dialysate to a first channel of the second dialysate pump;
a second valve configured to direct a first amount of regenerated dialysate to a second channel of the first dialysate pump and a second amount of regenerated dialysate to a second channel of the second dialysate pump;
a sorbent cartridge in fluid communication with the first dialysate pump and the second dialysate pump;
a third valve configured to aggregate spent dialysate from the first dialysate pump and the second dialysate pump into a single stream of spent dialysate and direct the single stream of spent dialysate to the sorbent cartridge; and
a fourth valve configured to aggregate regenerated dialysate from the first dialysate pump and the second dialysate pump into a single stream of regenerated dialysate and direct the single stream of regenerated dialysate to the dialyzer; and
a processor configured to reverse a state of the first valve, second valve, third valve, and fourth valve to reverse an action of the first dialysate pump and second dialysate pump such that, during the dialysis session, a volume of fluid that is pumped from the dialyzer equals a volume of fluid that is pumped into the dialyzer.

### Claim 2 (depends on 1)

The dialysis system of claim 1 wherein a total fluid volume lost by the dialysis circuit equals a volume of the waste fluid removed by the third pump.

### Claim 3 (depends on 1)

The dialysis system of claim 1 further comprising a pressure sensor positioned in a flow path between the first valve and the third pump.

### Claim 4 (depends on 1)

The dialysis system of claim 1 further comprising a container for storing waste drawn from the dialysate circuit by the third pump.

### Claim 5 (depends on 1)

The dialysis system of claim 1 further comprising a plastic manifold wherein a portion of the dialysate circuit and a portion of the blood circuit are housed by the plastic manifold.

### Claim 6 (depends on 5)

The dialysis system of claim 5, wherein the plastic manifold comprises a plurality of tubes, and wherein, when the plastic manifold is installed within the dialysis system, a portion of the plurality of tubes is positioned adjacent to each of each the first pump and the second pump such that, during operation, each of first pump and second pump applies a force to the portion of the plurality of tubes.

### Claim 7 (depends on 5)

The dialysis system of claim 5, further comprising an alignment mechanism for receiving and positioning the plastic manifold in the dialysis system.

### Claim 8 (depends on 7)

The dialysis system of claim 7, wherein the alignment mechanism comprises at least one of a plurality of holes in a surface of the plastic manifold, a plurality of tabs in a surface of the plastic manifold, or a plurality of contoured guides.

### Claim 9 (depends on 1)

The dialysis system of claim 1 further comprising:
a first container comprising a first material;
a second container comprising a second material;
a fifth valve in fluid communication with the first and second container, wherein, in a first state, the fifth valve places the first material in physical communication with the fluid in the dialysate circuit and wherein, in a second state, the fifth valve places the second material in physical communication with the fluid in the dialysate circuit.

### Claim 10 (depends on 9)

The dialysis system of claim 9, wherein the first material is concentrate.

### Claim 11 (depends on 9)

The dialysis system of claim 9, wherein the second material is infusate.

### Claim 12 (depends on 9)

The dialysis system of claim 9, further comprising a fourth pump configured to direct the first material and the second material into the fluid in the dialysate circuit.

### Claim 13 (depends on 1)

The dialysis system of claim 1, wherein the dialysate circuit further comprises a flow restrictor positioned after the sorbent.

### Claim 14 (depends on 1)

The dialysis system of claim 1, wherein a flow path between the dialyzer and sorbent cartridge comprises a flow restrictor, a temperature sensor, a flow sensor, and a pressure sensor.

### Claim 15 (depends on 1)

The dialysis system of claim 1, further comprising a sixth valve wherein, in a first state, the sixth valve directs a fluid into the dialysate side of the dialyzer and, in a second state, directs the fluid into the blood circuit.

### Claim 16 (depends on 15)

The dialysis system of claim 15, wherein, when operating in hemofiltration mode, the sixth valve is in the second state.

### Claim 17 (depends on 15)

The dialysis system of claim 15, wherein, when operating in hemodialysis mode, the sixth valve is in the first state.

### Claim 18 (depends on 15)

The dialysis system of claim 15, further comprising a seventh valve positioned between the sixth valve and a fluid pathway into the blood circuit wherein the seventh valve is configured to be a backup valve if the sixth valve leaks or fails.

### Claim 19 (depends on 1)

The dialysis system of claim 1, further comprising a fifth pump configured to apply pressure to a fluid pathway of the blood circuit.

### Claim 20 (depends on 1)

The dialysis system of claim 1, further comprising a blood leak sensor positioned at a point where fluid from the dialysate side of the dialyzer enters the dialysate circuit.