# US 11,992,343 B2 · Systems, devices, and methods for fluid monitoring

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,992,343 B2
- Document ID: US11992343B2
- Status: Granted
- Kind: B2
- Application number: 17/737,825
- Filed: 2022-05-05
- Published: 2022-10-13
- Granted: 2024-05-28
- Earliest claimed: 2019-06-26
- Assignees: Gastroklenz Inc.
- Applicants: GastroKlenz Inc.
- Inventors: Eric Hsiang Yu; Aly R. Elbadry; Carlos Rovira Borras; Daniel Elliott Francis
- Web page: https://patentgrep.com/patent/US11992343B2

## CPC

- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0059: {using light, e.g. diagnosis by transillumination, diascopy, fluorescence (photoacoustic A61B5/0093; optical measurement of heart rate A61B5/02416; optical measurement of blood flow A61B5/0261; optical measurement of analytes A61B5/1455)}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 5/412: {Detecting or monitoring sepsis}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 5/6866: {Extracorporeal blood circuits, e.g. dialysis circuits}
- A61M 1/152: {Details related to the interface between cassette and machine}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- G01N 15/06: Investigating concentration of particle suspensions (by weighing G01N5/00; investigating sedimentation of particle suspensions G01N15/04; investigating individual particles G01N15/10)
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/0261: {using optical means, e.g. infrared light}
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/208: {adapted to determine urine quantity, e.g. flow, volume}
- A61B 2560/04: Constructional details of apparatus
- A61B 2562/16: Details of sensor housings or probes; Details of structural supports for sensors (A61B2560/0462 takes precedence)
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 2205/3306: Optical measuring means
- G01N 15/075: by optical means
- G01N 2015/012: {Red blood cells}
- G01N 2015/016: {White blood cells}
- G01N 2015/0687: {in solutions, e.g. non volatile residue}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Devices, systems, and methods herein relate to predicting infection of a patient. These systems and methods may comprise illuminating a patient fluid in a fluid conduit from a plurality of illumination directions, measuring an optical characteristic of the illuminated patient fluid using one or more sensors, and predicting an infection state of the patient based at least in part on the measured optical characteristic.

## Claims

### Claim 1

A method of monitoring patient fluid from a patient, comprising:
illuminating the patient fluid in a fluid conduit from a plurality of illumination directions;
measuring an optical characteristic of the illuminated patient fluid using one or more sensors;
estimating a fluid flow rate in the fluid conduit based at least in part on the measured optical characteristic; and
predicting an infection state of the patient based at least in part on the estimated fluid flow rate and the measured optical characteristic.

### Claim 2 (depends on 1)

The method of claim 1, wherein illuminating the patient fluid comprises activating illumination based on the estimated fluid flow rate.

### Claim 3 (depends on 1)

The method of claim 1, further comprising determining a fluid flow state comprising detecting at least one of an ON state and an OFF state based on the estimated fluid flow rate, wherein illuminating the patient fluid comprises activating illumination in response to detecting the ON state and ceasing illumination in response to detecting the OFF state.

### Claim 4 (depends on 3)

The method of claim 3, wherein a drain pumping state of a peritoneal dialysis cycler corresponds to the ON state and the OFF state.

### Claim 5 (depends on 1)

The method of claim 1, further comprising identifying a false positive drain pumping state based on the estimated fluid flow rate.

### Claim 6 (depends on 5)

The method of claim 5, wherein identifying the false positive drain pumping state includes not identifying an ON state over two or more successive time measurement periods.

### Claim 7 (depends on 6)

The method of claim 6, wherein a predetermined delay time period is between the successive time measurement periods.

### Claim 8 (depends on 5)

The method of claim 5, wherein the estimated fluid flow rate comprises a predetermined number of measured pump pulses over a predetermined duration of fluid flow.

### Claim 9 (depends on 1)

The method of claim 1, wherein the estimated fluid flow rate is further based at least in part on one or more attenuation light intensity measurements from the one or more sensors.

### Claim 10 (depends on 1)

The method of claim 1, wherein measuring the optical characteristic comprises sampling the patient fluid at about 75 Hz.

### Claim 11 (depends on 10)

The method of claim 10, further comprising:
analyzing a frequency response of the measured optical characteristic; and
determining a fluid flow state comprising detecting at least one of an ON state and an OFF state based on the frequency response.

### Claim 12 (depends on 1)

The method of claim 1, further comprising analyzing a frequency response of the measured optical characteristic, wherein estimating the fluid flow rate is based at least in part on the frequency response.

### Claim 13 (depends on 12)

The method of claim 12, wherein analyzing the frequency response comprises passing the measured optical characteristic through one or more filters to generate a filtered signal.

### Claim 14 (depends on 13)

The method of claim 13, further comprising determining a drain pumping state comprising detecting at least one of an ON state and an OFF state based on the generated filtered signal.

### Claim 15 (depends on 14)

The method of claim 14, wherein the filtered signal comprising a predetermined number of pulses above a predetermined threshold corresponds to the ON state.

### Claim 16 (depends on 13)

The method of claim 13, wherein the one or more filters comprises one or more of a first filter comprising a low pass filter, and a second filter comprising a high pass filter.

### Claim 17 (depends on 1)

The method of claim 1, wherein the frequency response between about 0.05 Hz and about 0.2 Hz corresponds to the ON state, and the frequency response not between about 0.05 Hz and about 0.2 Hz corresponds to the OFF state.

### Claim 18 (depends on 1)

The method of claim 1, wherein estimating the fluid flow rate in the fluid conduit based at least in part on one or more non-optical sensors.

### Claim 19 (depends on 18)

The method of claim 18, wherein the one or more non-optical sensors comprise one or more of an accelerometer, a pressure sensor, and a microphone.

### Claim 20 (depends on 1)

The method of claim 1, further comprising detecting bubbles in the fluid conduit based at least in part on the optical measurement.

### Claim 21 (depends on 20)

The method of claim 20, further comprising excluding the optical measurement corresponding to the detected bubbles from the infection state prediction.

### Claim 22 (depends on 1)

The method of claim 1, wherein predicting the infection state comprises generating an infection score.

### Claim 23 (depends on 22)

The method of claim 22, wherein the infection score is based at least in part on the measured optical characteristics of the illuminated patient fluid at one or more wavelengths.

### Claim 24 (depends on 22)

The method of claim 22, wherein predicting the infection state comprises predicting infection in response to the infection score exceeding one or more predetermined thresholds during each of one or more successive measurement time periods.

### Claim 25 (depends on 22)

The method of claim 22, wherein predicting the infection state comprises predicting infection based on a rate of change of the infection score over time.

### Claim 26 (depends on 22)

The method of claim 22, wherein predicting the infection state comprises predicting infection in response to any one or more of the following: the infection score exceeding one or more predetermined thresholds during each of one or more successive measurement time periods, the infection score changing from a patient baseline over time, and the infection score having an increasing rate of change over time.

### Claim 27 (depends on 22)

The method of claim 22, further comprising monitoring a trend in infection score and predicting infection resolution of the patient based on the monitored trend.

### Claim 28 (depends on 27)

The method of claim 27, wherein predicting infection resolution comprises predicting infection resolution in response to any one or more of the following: the infection score falling below one or more predetermined thresholds during each of one or more successive measurement time periods, the infection score decreasing from a patient baseline over time, and the infection score having a decreasing rate of change over time.

### Claim 29 (depends on 1)

The method of claim 1, further comprising estimating a particle concentration of the patient fluid based at least in part on the measured optical characteristic.

### Claim 30 (depends on 1)

The method of claim 1, wherein the fluid conduit comprises a circular cross-section portion with a first cross-sectional area and a square cross-section portion with a second cross-sectional area, wherein the optical characteristic is measured as the fluid transitions from the circular cross-section portion to the square cross-section portion.
