# US 12,178,944 B2 · Optical sensor for determining a dialysis dose

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- Number: US 12,178,944 B2
- Document ID: US12178944B2
- Status: Granted
- Kind: B2
- Application number: 18/564,074
- Filed: 2022-05-25
- Published: 2024-08-15
- Granted: 2024-12-31
- Earliest claimed: 2021-05-26
- Assignees: B. Braun Avitum AG
- Applicants: B. Braun Avitum AG
- Inventors: Waldemar Janik
- Web page: https://patentgrep.com/patent/US12178944B2

## CPC

- A61M 1/1609: {after use, i.e. downstream of dialyser}
- A61M 2202/0498: Urea
- A61M 2205/3306: Optical measuring means
- 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 device for determining a dialysis efficiency/dialysis dose of an extracorporeal blood treatment process has a radiation source, a cuvette, a detection unit and a control unit. The radiation source emits radiation, the intensity of which is controlled by adjusting a current intensity applied to the radiation source. The cuvette is preferably provided with an inlet and outlet, and is penetrated by radiation emitted by the radiation source. The detection unit detects the intensity of the radiation after the radiation passes the cuvette. The control unit determines the dialysis efficiency/dialysis dose from the intensity detected by the detection unit. The control unit, which is connected to the radiation source and detection unit, reduces the intensity of the radiation by adjusting the current intensity during the extracorporeal blood treatment process at least once, based on a drop in concentration of substances excreted in the urine in the dialysis fluid.

## Claims

### Claim 1

A device for determining a dialysis efficiency/dialysis dose of an extracorporeal blood treatment with a radiation source, a cuvette, at least one detection unit and a regulation/control unit, wherein
the radiation source is intended and configured to emit a radiation, the intensity of which is controlled/regulated by adjusting a current strength to which the radiation source is subjected,
the cuvette is provided with a dialysis fluid inlet and a dialysis fluid outlet and is intended and configured to be penetrated by the radiation emitted by the radiation source,
the detection unit is provided and adapted to detect, as a measurement detection unit, the intensity of the radiation after it has passed the cuvette,
the regulation/control unit determines the dialysis efficiency/dialysis dose from the intensity of the radiation detected by the detection unit,
wherein
the regulation/control unit is connected to the radiation source and the detection unit and is provided and configured to reduce the intensity of the emitted radiation by adjusting the current strength over the time course of the extracorporeal blood treatment at least once, based on a decrease in a concentration of urinary substances in the dialysis fluid.

### Claim 2 (depends on 1)

The device according to claim 1, wherein the regulation/control unit is provided and configured to control the radiation source in such a way that the intensity of the radiation detected by the detection unit remains constant over the time course of the extracorporeal blood treatment.

### Claim 3 (depends on 2)

The device according to claim 2, wherein the current strength applied to the radiation source is evaluated/used for determining the dialysis efficiency/dialysis dose.

### Claim 4 (depends on 3)

The device according to claim 3, wherein the dialysis efficiency/dialysis dose is the Kt/V value, where K describes the clearance, t the therapy duration and V the patient-specific distribution volume of urea in the body, and the regulation/control unit is provided and configured to determine the dialysis efficiency/dialysis dose via the rule Kt/V=ln(I(t3)/I(t)), where I describes the current strength, t3 a fixed point in time and t the therapy duration.

### Claim 5 (depends on 3)

The device according to claim 3, wherein the dialysis efficiency/dialysis dose is the Kt/V value, where K describes the clearance, t the therapy duration and V the patient-specific distribution volume of urea in the body, and the regulation/control unit is provided and configured to determine the dialysis efficiency/dialysis dose via the rule Kt/V=−ln(−0.008*t+(I(t)/I(t3))+(4−3.5*(I(t)/I(t3))*UF/W, where I describes the current strength, t3 describes a fixed point in time, t describes the therapy duration, UF describes the ultrafiltration volume and W describes the weight of the patient.

### Claim 6 (depends on 3)

The device according to claim 3, wherein the current strength is normalized to a reference temperature value.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the device comprises a further detection unit provided and configured to detect the intensity of the radiation emitted from the radiation source as a reference detection unit, wherein the course of therapy comprises at least one regulation phase and at least one measuring phase, wherein the regulation/control unit reduces the intensity of the emitted radiation over the time course of the extracorporeal blood treatment at least once in the regulation phase and the regulation/control unit controls the radiation source by adjusting the current strength in such a way that the intensity of the radiation detected by the reference detection unit remains constant during the measuring phase and the intensity of the radiation is evaluated at the measuring detection unit for determining the dialysis efficiency/dialysis dose during the measuring phase.

### Claim 8 (depends on 7)

The device according to claim 7, wherein the regulation phase and/or the measuring phase are triggered by therapy parameters.

### Claim 9 (depends on 7)

The device according to claim 7, wherein the regulation phase and the measuring phase are performed at defined times of the extracorporeal blood treatment.

### Claim 10 (depends on 7)

The device according to claim 7, wherein an opacity of the cuvette is determined by a ratio change between the intensity of the radiation detected at the measuring detection unit and the intensity of the radiation detected at the reference detection unit.

### Claim 11 (depends on 1)

The device according to claim 1, wherein the current strengths and the duration with which the radiation source is subjected to the current strengths are stored and a prediction of the lifetime of the radiation source is carried out via these stored values.

### Claim 12 (depends on 1)

The device according to claim 1, wherein the cuvette is arranged between the radiation source and the measuring detection unit.