# US 11,998,673 B1 · Extracorporeal blood filtering machine and methods

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- Number: US 11,998,673 B1
- Document ID: US11998673B1
- Status: Granted
- Kind: B1
- Application number: 18/171,640
- Filed: 2023-02-20
- Granted: 2024-06-04
- Earliest claimed: 2023-02-20
- Assignees: Nuwellis, Inc.
- Applicants: Nuwellis, Inc.
- Inventors: Vitaliy Gennad'yevich Epshteyn; Steven Daniel Sandoval; Kalley Francis Berg; Franz Willems Ulrich
- Web page: https://patentgrep.com/patent/US11998673B1

## CPC

- A61M 1/154: {with sensing means or components thereof}
- A61M 1/1601: {Control or regulation}
- A61M 1/1603: {Regulation parameters}
- A61M 1/1692: {Detection of blood traces in dialysate}
- A61M 1/3455: {Substitution fluids}
- A61M 1/3465: {using dialysate as substitution fluid}
- A61M 1/36224: {with sensing means or components thereof}
- A61J 1/10: Bag-type containers
- A61M 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/15632: {the filter being a dialyser}
- A61M 1/1566: {Means for adding solutions or substances to the treating fluid}
- A61M 1/16: with membranes
- A61M 1/1643: {with weighing of fresh and used dialysis fluid}
- A61M 1/1694: {with recirculating dialysing liquid}
- 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 1/341: {by measuring the filtrate rate or volume}
- A61M 1/3413: {Diafiltration}
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3424: {Substitution fluid path}
- 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 1/3441: {Substitution rate control as a function of the ultrafiltration rate}
- 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 1/3607: {Regulation parameters}
- A61M 1/361: {before treatment}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/362262: {Details of incorporated reservoirs}
- A61M 1/362264: {the filter being a blood filter}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- 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 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3644: {Mode of operation}
- A61M 1/3663: {Flow rate transducers; Flow integrators}
- A61M 1/3672: {Means preventing coagulation}
- A61M 5/1415: {Stands, brackets or the like for supporting infusion accessories}
- A61M 5/165: Filtering accessories, e.g. blood filters, filters for infusion liquids (A61M1/34, A61M5/36 take precedence)
- A61M 5/172: electrical or electronic
- A61M 60/109: incorporated within extracorporeal blood circuits or systems
- A61M 60/268: the displacement member being flexible, e.g. membranes, diaphragms or bladders
- A61M 2202/0042: filtrate, i.e. the fluid passing through the filter
- A61M 2205/3306: Optical measuring means
- A61M 2205/3313: used specific wavelengths
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3368: Temperature
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3393: by weighing the reservoir
- A61M 2205/50: with microprocessors or computers
- 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 2205/82: Internal energy supply devices
- A61M 2205/8206: battery-operated
- A61M 2205/8262: connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter
- A61M 2209/082: Mounting brackets, arm supports for equipment
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/207: hematocrit
- 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)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

An extracorporeal blood filtering machine can include a blood circuit, an effluent circuit, and a source fluid circuit and can be controlled by a controller. The extracorporeal blood filtering machine can also include access ports for connecting the source fluid circuit to the blood circuit, as well as blood sensors to detect possible issues with the extracorporeal blood filtering machine. The extracorporeal blood filtering machine can include density sensors and flow sensors that enable it to be more accurate and to operate while being transported. The extracorporeal blood filtering machine can further include a user interface and can display fluid inflow/outflow information. A medical fluid container can automatically empty after being filled. An apparatus for supporting a medical fluid container can include a hanger and an attachment member with the apparatus able to adjust to ensure the medical fluid container remains properly oriented directly under a medical fluid container scale.

## Claims

### Claim 1

An extracorporeal blood filtering machine comprising:
a blood circuit that includes:
a blood line comprising a blood inlet configured to receive blood from a patient and a blood outlet configured to return the blood to the patient,
a filter fluidly connected to the blood line between the blood inlet and the blood outlet, and
a blood pump configured to pump the blood at a blood pump speed from the blood inlet to the blood outlet through the filter, the filter configured to remove waste from the blood;
a source fluid circuit that includes:
a source fluid line fluidly connected to a source fluid reservoir and configured to be connected to the blood circuit, and
a source fluid pump configured to pump source fluid at a source fluid pump speed from the source fluid reservoir through the source fluid line into the blood circuit;
an effluent circuit that includes:
an effluent line fluidly connected to the filter, the effluent line configured to receive the waste from the filter in the form of effluent, and
an effluent pump configured to pump the effluent at an effluent pump speed from the filter through the effluent line into an effluent receptacle;
a source fluid flow sensor configured to measure a source fluid flow quantity;
an effluent flow sensor configured to measure an effluent flow quantity; and
a controller in communication with the blood pump, the source fluid pump, and the effluent pump, the controller configured to operate the extracorporeal blood filtering machine in an open-loop mode or in a closed-loop mode, the controller setting the blood pump speed, the source fluid pump speed, and the effluent pump speed at respective fixed speeds in the open-loop mode, the controller adjusting the source fluid pump speed based on the source fluid flow quantity in the closed-loop mode, and the controller adjusting the effluent pump speed based on the effluent flow quantity in the closed-loop mode,
wherein the effluent receptacle comprises a drain when the controller is operating the extracorporeal blood filtering machine in the open-loop mode, and the effluent receptacle comprises a bag when the controller is operating the extracorporeal blood filtering machine in the closed-loop mode.

### Claim 2 (depends on 1)

The extracorporeal blood filtering machine of claim 1, wherein the effluent flow sensor comprises an effluent scale configured to measure a dynamic effluent weight value of the effluent receptacle.

### Claim 3 (depends on 1)

The extracorporeal blood filtering machine of claim 1, wherein the effluent flow sensor is in fluid communication with the effluent line and is configured to measure an effluent fluid volume.

### Claim 4 (depends on 1)

The extracorporeal blood filtering machine of claim 1, wherein the source fluid flow sensor comprises a source fluid scale configured to measure a dynamic source fluid weight value of the source fluid reservoir.

### Claim 5 (depends on 1)

The extracorporeal blood filtering machine of claim 1, wherein the source fluid flow sensor is in fluid communication with the source fluid line and is configured to measure a source fluid volume.

### Claim 6 (depends on 1)

The extracorporeal blood filtering machine of claim 1, further comprising a secondary source fluid flow sensor configured to measure a secondary source fluid flow quantity in the source fluid line at a location different from the source fluid flow sensor.

### Claim 7 (depends on 6)

The extracorporeal blood filtering machine of claim 6, wherein the controller is configured to compare the secondary source fluid flow quantity with the source fluid flow quantity and output a source fluid flow mismatch alert if a first difference between the secondary source fluid flow quantity and the source fluid flow quantity exceeds a first threshold.

### Claim 8 (depends on 1)

The extracorporeal blood filtering machine of claim 1, further comprising a secondary effluent flow sensor, the secondary effluent flow sensor configured to measure a secondary effluent flow quantity in the effluent line at a location different from the effluent flow sensor.

### Claim 9 (depends on 8)

The extracorporeal blood filtering machine of claim 8, wherein the controller is configured to compare the secondary effluent flow quantity with the effluent flow quantity and output a flow mismatch alert if a second difference between the secondary effluent flow quantity and the effluent flow quantity exceeds a second threshold.

### Claim 10 (depends on 8)

The extracorporeal blood filtering machine of claim 8, further comprising a secondary source fluid flow sensor configured to measure a secondary source fluid flow quantity in the source fluid line at a location different from the source fluid flow sensor, wherein the controller is configured to compare the secondary source fluid flow quantity with the source fluid flow quantity and output a source fluid flow mismatch alert if a first difference between the secondary source fluid flow quantity and the source fluid flow quantity exceeds a first threshold.

### Claim 11 (depends on 8)

The extracorporeal blood filtering machine of claim 8, wherein the controller is further configured to switch between the open-loop mode and the closed-loop mode based on a user input.

### Claim 12 (depends on 1)

The extracorporeal blood filtering machine of claim 1, wherein the controller is further configured to switch between the open-loop mode and the closed-loop mode based on a user input.